{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T05:10:49Z","timestamp":1790745049146,"version":"4.1.0"},"reference-count":52,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,11,6]],"date-time":"2021-11-06T00:00:00Z","timestamp":1636156800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,11,6]],"date-time":"2021-11-06T00:00:00Z","timestamp":1636156800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000071","name":"National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["R01HD101528"],"award-info":[{"award-number":["R01HD101528"]}],"id":[{"id":"10.13039\/100000071","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Department of Public Health, Pennsylvania","award":["SAP #4100085749"],"award-info":[{"award-number":["SAP #4100085749"]}]},{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","award":["173498"],"award-info":[{"award-number":["173498"]}],"id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Medical Research Futures Fund International Clinical Trial Collaboration","award":["APP1190814"],"award-info":[{"award-number":["APP1190814"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background\/aims<\/jats:title>\n                    <jats:p>Despite evidence that preferential use of balanced\/buffered fluids may improve outcomes compared with chloride-rich 0.9% saline, saline remains the most commonly used fluid for children with septic shock. We aim to determine if resuscitation with balanced\/buffered fluids as part of usual care will improve outcomes, in part through reduced kidney injury and without an increase in adverse effects, compared to 0.9% saline for children with septic shock.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The Pragmatic Pediatric Trial of Balanced versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) study is an international, open-label pragmatic interventional trial being conducted at &gt;\u200940 sites in the USA, Canada, and Australia\/New Zealand starting on August 25, 2020, and continuing for 5 years. Children &gt;\u20096\u2009months to &lt;\u200918\u2009years treated for suspected septic shock with abnormal perfusion in an emergency department will be randomized to receive either balanced\/buffered crystalloids (intervention) or 0.9% saline (control) for initial resuscitation and maintenance fluids for up to 48\u2009h. Eligible patients are enrolled and randomized using serially numbered, opaque envelopes concurrent with clinical care. Given the life-threatening nature of septic shock and narrow therapeutic window to start fluid resuscitation, patients may be enrolled under \u201cexception from informed consent\u201d in the USA or \u201cdeferred consent\u201d in Canada and Australia\/New Zealand. Other than fluid type, all decisions about timing, volume, and rate of fluid administration remain at the discretion of the treating clinicians. For pragmatic reasons, clinicians will not be blinded to study fluid type. Anticipated enrollment is 8800 patients. The primary outcome will be major adverse kidney events within 30\u2009days (MAKE30), a composite of death, renal replacement therapy, and persistent kidney dysfunction. Additional effectiveness, safety, and biologic outcomes will also be analyzed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>PRoMPT BOLUS will provide high-quality evidence for the comparative effectiveness of buffered\/balanced crystalloids versus 0.9% saline for the initial fluid management of children with suspected septic shock in emergency settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      PRoMPT BOLUS was first registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\" ext-link-type=\"uri\">ClinicalTrials.gov<\/jats:ext-link>\n                      (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04102371\" ext-link-type=\"uri\">NCT04102371<\/jats:ext-link>\n                      ) on September 25, 2019. Enrollment started on August 25, 2020.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-021-05717-4","type":"journal-article","created":{"date-parts":[[2021,11,6]],"date-time":"2021-11-06T14:02:26Z","timestamp":1636207346000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":52,"title":["PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7040-3281","authenticated-orcid":false,"given":"Scott L.","family":"Weiss","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran","family":"Balamuth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elliot","family":"Long","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham C.","family":"Thompson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie L.","family":"Hayes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Katcoff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlena","family":"Cook","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Tsemberis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher P.","family":"Hickey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Williams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Williamson-Urquhart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meredith L.","family":"Borland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart R.","family":"Dalziel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben","family":"Gelbart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen B.","family":"Freedman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franz E.","family":"Babl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan","family":"Kuppermann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Long","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Williams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Babl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Borland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"O\u2019Brien","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Craig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Ramaga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Kochar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Nivea","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Jani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Thosar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Rao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Phillips","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"George","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Lithgow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Mitchell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Thompson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Freedman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Williamson-Urquhart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Gilad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Cooke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Judge","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Murthy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Kissoon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.","family":"Alqurashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Alnaji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Sangha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Mater","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Brashaw","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Curtis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Joffe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y.","family":"Shayan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Tucci","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Gripp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Berthelot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Weiss","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Davis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Guifoyle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Moretti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Kam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Parker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"Rochwerg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Emsley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Verma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Sehgal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Dalziel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Bonisch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Tan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Neutze","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Balamuth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Weiss","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Tsemberis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Cook","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Katcoff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Hayes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Hickey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Eisenberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Lewander","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Morris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Hurley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Baumer-Mouradian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Ambroggio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Grice","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Festekjian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"Hickey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Sada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Dodson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Badawy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Lebel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Elliott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I.","family":"Koutroulis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Hom","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Eckerle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Singleton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Rogers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Cervantes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Duffy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I.","family":"Bahamon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Alpern","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Sirizi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. Haider","family":"Ahmad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. Rubi","family":"Banegas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Lloyd","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"DiCostanzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Kwok","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Ochs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Lane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Harbour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Uspal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Cappetto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Clukies","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Robinsonm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"McManemy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Gonzales","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Vance","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Kupperman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Pimenta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Mansour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Lavrisha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Ramirez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Grad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,11,6]]},"reference":[{"issue":"10219","key":"5717_CR1","doi-asserted-by":"publisher","first-page":"200","DOI":"10.1016\/S0140-6736(19)32989-7","volume":"395","author":"KE Rudd","year":"2020","unstructured":"Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020;395(10219):200\u201311. https:\/\/doi.org\/10.1016\/S0140-6736(19)32989-7.","journal-title":"Lancet."},{"issue":"6","key":"5717_CR2","doi-asserted-by":"publisher","first-page":"537","DOI":"10.1097\/MCC.0000000000000028","volume":"19","author":"N Karakala","year":"2013","unstructured":"Karakala N, Raghunathan K, Shaw AD. Intravenous fluids in sepsis: what to use and what to avoid. Curr Opin Crit Care. 2013;19(6):537\u201343. https:\/\/doi.org\/10.1097\/MCC.0000000000000028.","journal-title":"Curr Opin Crit Care."},{"issue":"13","key":"5717_CR3","doi-asserted-by":"publisher","first-page":"1243","DOI":"10.1056\/NEJMra1208627","volume":"369","author":"JA Myburgh","year":"2013","unstructured":"Myburgh JA, Mythen MG. Resuscitation fluids. N Engl J Med. 2013;369(13):1243\u201351. https:\/\/doi.org\/10.1056\/NEJMra1208627.","journal-title":"N Engl J Med."},{"issue":"17","key":"5717_CR4","doi-asserted-by":"publisher","first-page":"1809","DOI":"10.1001\/jama.2013.280502","volume":"310","author":"D Annane","year":"2013","unstructured":"Annane D, Siami S, Jaber S, Martin C, Elatrous S, Declere AD, et al. Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. JAMA. 2013;310(17):1809\u201317. https:\/\/doi.org\/10.1001\/jama.2013.280502.","journal-title":"JAMA."},{"issue":"7","key":"5717_CR5","doi-asserted-by":"publisher","first-page":"1585","DOI":"10.1097\/CCM.0000000000000305","volume":"42","author":"K Raghunathan","year":"2014","unstructured":"Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, et al. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014;42(7):1585\u201391. https:\/\/doi.org\/10.1097\/CCM.0000000000000305.","journal-title":"Crit Care Med."},{"issue":"9","key":"5717_CR6","doi-asserted-by":"publisher","first-page":"1561","DOI":"10.1007\/s00134-015-3794-1","volume":"41","author":"B Rochwerg","year":"2015","unstructured":"Rochwerg B, Alhazzani W, Gibson A, Ribic CM, Sindi A, Heels-Ansdell D, et al. Fluid type and the use of renal replacement therapy in sepsis: a systematic review and network meta-analysis. Intensive Care Med. 2015;41(9):1561\u201371. https:\/\/doi.org\/10.1007\/s00134-015-3794-1.","journal-title":"Intensive Care Med."},{"issue":"5","key":"5717_CR7","doi-asserted-by":"publisher","first-page":"347","DOI":"10.7326\/M14-0178","volume":"161","author":"B Rochwerg","year":"2014","unstructured":"Rochwerg B, Alhazzani W, Sindi A, Heels-Ansdell D, Thabane L, Fox-Robichaud A, et al. Fluid resuscitation in sepsis: a systematic review and network meta-analysis. Ann Intern Med. 2014;161(5):347\u201355. https:\/\/doi.org\/10.7326\/M14-0178.","journal-title":"Ann Intern Med."},{"issue":"5","key":"5717_CR8","doi-asserted-by":"publisher","first-page":"821","DOI":"10.1097\/SLA.0b013e31825074f5","volume":"255","author":"AD Shaw","year":"2012","unstructured":"Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, et al. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012;255(5):821\u20139. https:\/\/doi.org\/10.1097\/SLA.0b013e31825074f5.","journal-title":"Ann Surg."},{"issue":"2","key":"5717_CR9","doi-asserted-by":"publisher","first-page":"255","DOI":"10.1097\/SLA.0b013e318295feba","volume":"259","author":"JB Young","year":"2014","unstructured":"Young JB, Utter GH, Schermer CR, Galante JM, Phan HH, Yang Y, et al. Saline versus Plasma-Lyte A in initial resuscitation of trauma patients: a randomized trial. Ann Surg. 2014;259(2):255\u201362. https:\/\/doi.org\/10.1097\/SLA.0b013e318295feba.","journal-title":"Ann Surg."},{"issue":"15","key":"5717_CR10","doi-asserted-by":"publisher","first-page":"1566","DOI":"10.1001\/jama.2012.13356","volume":"308","author":"NM Yunos","year":"2012","unstructured":"Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012;308(15):1566\u201372. https:\/\/doi.org\/10.1001\/jama.2012.13356.","journal-title":"JAMA."},{"issue":"3","key":"5717_CR11","doi-asserted-by":"publisher","first-page":"532","DOI":"10.4103\/0259-1162.181425","volume":"10","author":"A Sharma","year":"2016","unstructured":"Sharma A, Yadav M, Kumar BR, Lakshman PS, Iyenger R, Ramchandran G. A comparative study of Sterofundin and Ringer lactate based infusion protocol in scoliosis correction surgery. Anesth Essays Res. 2016;10(3):532\u20137. https:\/\/doi.org\/10.4103\/0259-1162.181425.","journal-title":"Anesth Essays Res."},{"issue":"16","key":"5717_CR12","doi-asserted-by":"publisher","first-page":"1701","DOI":"10.1001\/jama.2015.12334","volume":"314","author":"P Young","year":"2015","unstructured":"Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, et al. Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit: The SPLIT Randomized Clinical Trial. JAMA. 2015;314(16):1701\u201310. https:\/\/doi.org\/10.1001\/jama.2015.12334.","journal-title":"JAMA."},{"issue":"2","key":"5717_CR13","doi-asserted-by":"publisher","first-page":"204","DOI":"10.1086\/318479","volume":"32","author":"NT Ngo","year":"2001","unstructured":"Ngo NT, Cao XT, Kneen R, Wills B, Nguyen VM, Nguyen TQ, et al. Acute management of dengue shock syndrome: a randomized double-blind comparison of 4 intravenous fluid regimens in the first hour. Clin Infect Dis. 2001;32(2):204\u201313.","journal-title":"Clin Infect Dis."},{"issue":"2","key":"5717_CR14","doi-asserted-by":"publisher","first-page":"179","DOI":"10.1016\/j.clnu.2008.01.008","volume":"27","author":"S Awad","year":"2008","unstructured":"Awad S, Allison SP, Lobo DN. The history of 0.9% saline. Clin Nutr. 2008;27(2):179\u201388. https:\/\/doi.org\/10.1016\/j.clnu.2008.01.008.","journal-title":"Clin Nutr."},{"issue":"3","key":"5717_CR15","doi-asserted-by":"publisher","first-page":"245","DOI":"10.1111\/1742-6723.12400","volume":"27","author":"E Long","year":"2015","unstructured":"Long E, Babl F, Dalziel S, Dalton S, Etheridge C, Duke T, et al. Fluid resuscitation for paediatric sepsis: A survey of senior emergency physicians in Australia and New Zealand. Emerg Med Australas. 2015;27(3):245\u201350. https:\/\/doi.org\/10.1111\/1742-6723.12400.","journal-title":"Emerg Med Australas."},{"issue":"4","key":"5717_CR16","doi-asserted-by":"publisher","first-page":"391","DOI":"10.1016\/j.jemermed.2015.03.012","volume":"49","author":"GC Thompson","year":"2015","unstructured":"Thompson GC, Macias CG. Recognition and Management of Sepsis in Children: Practice Patterns in the Emergency Department. J Emerg Med. 2015;49(4):391\u20139. https:\/\/doi.org\/10.1016\/j.jemermed.2015.03.012.","journal-title":"J Emerg Med."},{"issue":"9","key":"5717_CR17","doi-asserted-by":"publisher","first-page":"829","DOI":"10.1056\/NEJMoa1711584","volume":"378","author":"MW Semler","year":"2018","unstructured":"Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, et al. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018;378(9):829\u201339. https:\/\/doi.org\/10.1056\/NEJMoa1711584.","journal-title":"N Engl J Med."},{"issue":"9","key":"5717_CR18","doi-asserted-by":"publisher","first-page":"819","DOI":"10.1056\/NEJMoa1711586","volume":"378","author":"WH Self","year":"2018","unstructured":"Self WH, Semler MW, Wanderer JP, Wang L, Byrne DW, Collins SP, et al. Balanced Crystalloids versus Saline in Noncritically Ill Adults. N Engl J Med. 2018;378(9):819\u201328. https:\/\/doi.org\/10.1056\/NEJMoa1711586.","journal-title":"N Engl J Med."},{"issue":"7","key":"5717_CR19","doi-asserted-by":"publisher","first-page":"1177","DOI":"10.1097\/CCM.0000000000002365","volume":"45","author":"ET Emrath","year":"2017","unstructured":"Emrath ET, Fortenberry JD, Travers C, McCracken CE, Hebbar KB. Resuscitation With Balanced Fluids Is Associated With Improved Survival in Pediatric Severe Sepsis. Crit Care Med. 2017;45(7):1177\u201383. https:\/\/doi.org\/10.1097\/CCM.0000000000002365.","journal-title":"Crit Care Med."},{"key":"5717_CR20","doi-asserted-by":"publisher","first-page":"304","DOI":"10.1016\/j.jpeds.2016.11.075","volume":"182","author":"SL Weiss","year":"2017","unstructured":"Weiss SL, Keele L, Balamuth F, Vendetti N, Ross R, Fitzgerald JC, et al. Crystalloid Fluid Choice and Clinical Outcomes in Pediatric Sepsis: A Matched Retrospective Cohort Study. J Pediatr. 2017;182:304\u201310 e10. https:\/\/doi.org\/10.1016\/j.jpeds.2016.11.075.","journal-title":"J Pediatr."},{"issue":"2","key":"5717_CR21","doi-asserted-by":"publisher","first-page":"e52","DOI":"10.1097\/PCC.0000000000002198","volume":"21","author":"SL Weiss","year":"2020","unstructured":"Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, et al. Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children. Pediatr Crit Care Med. 2020;21(2):e52\u2013e106. https:\/\/doi.org\/10.1097\/PCC.0000000000002198.","journal-title":"Pediatr Crit Care Med."},{"issue":"Suppl 1","key":"5717_CR22","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1007\/s00134-019-05878-6","volume":"46","author":"SL Weiss","year":"2020","unstructured":"Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, et al. Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children. Intensive Care Med. 2020;46(Suppl 1):10\u201367. https:\/\/doi.org\/10.1007\/s00134-019-05878-6.","journal-title":"Intensive Care Med."},{"issue":"nov11 2","key":"5717_CR23","doi-asserted-by":"publisher","first-page":"a2390","DOI":"10.1136\/bmj.a2390","volume":"337","author":"M Zwarenstein","year":"2008","unstructured":"Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337(nov11 2):a2390. https:\/\/doi.org\/10.1136\/bmj.a2390.","journal-title":"BMJ."},{"issue":"5","key":"5717_CR24","doi-asserted-by":"publisher","first-page":"464","DOI":"10.1016\/j.jclinepi.2008.12.011","volume":"62","author":"KE Thorpe","year":"2009","unstructured":"Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009;62(5):464\u201375. https:\/\/doi.org\/10.1016\/j.jclinepi.2008.12.011.","journal-title":"J Clin Epidemiol."},{"issue":"12","key":"5717_CR25","doi-asserted-by":"publisher","first-page":"1346","DOI":"10.1111\/acem.13815","volume":"26","author":"F Balamuth","year":"2019","unstructured":"Balamuth F, Kittick M, McBride P, Woodford A, Vestal N, Casper TC, et al. Pragmatic pediatric trial of balanced versus normal saline fluid in sepsis: the PRoMPT BOLUS pilot feasibility study. Acad Emerg Med. 2019;26(12):1346\u201356. https:\/\/doi.org\/10.1111\/acem.13815.","journal-title":"Acad Emerg Med."},{"issue":"11","key":"5717_CR26","doi-asserted-by":"publisher","first-page":"1040","DOI":"10.1197\/j.aem.2005.06.022","volume":"12","author":"D Watters","year":"2005","unstructured":"Watters D, Sayre MR, Silbergleit R. Research conditions that qualify for emergency exception from informed consent. Acad Emerg Med. 2005;12(11):1040\u20134. https:\/\/doi.org\/10.1197\/j.aem.2005.06.022.","journal-title":"Acad Emerg Med."},{"issue":"11","key":"5717_CR27","doi-asserted-by":"publisher","first-page":"1009","DOI":"10.1097\/PCC.0000000000001301","volume":"18","author":"K Menon","year":"2017","unstructured":"Menon K, O'Hearn K, McNally JD, Acharya A, Wong HR, Lawson M, et al. Comparison of Consent Models in a Randomized Trial of Corticosteroids in Pediatric Septic Shock. Pediatr Crit Care Med. 2017;18(11):1009\u201318. https:\/\/doi.org\/10.1097\/PCC.0000000000001301.","journal-title":"Pediatr Crit Care Med."},{"key":"5717_CR28","unstructured":"The National Health and Medical Research Council tARCaUA. National Statement on Ethical Conduct in Human Research Commonwealth of Australia, Canberra2007 (updated 2018) [Available from: https:\/\/www.nhmrc.gov.au\/about-us\/publications\/national-statement-ethical-conduct-human-research-2007-updated-2018."},{"issue":"11","key":"5717_CR29","doi-asserted-by":"publisher","first-page":"1071","DOI":"10.1197\/j.aem.2005.06.020","volume":"12","author":"JM Baren","year":"2005","unstructured":"Baren JM, Fish SS. Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent? Acad Emerg Med. 2005;12(11):1071\u20137. https:\/\/doi.org\/10.1197\/j.aem.2005.06.020.","journal-title":"Acad Emerg Med."},{"issue":"16","key":"5717_CR30","doi-asserted-by":"publisher","first-page":"1652","DOI":"10.1001\/jama.2014.2625","volume":"311","author":"JM Chamberlain","year":"2014","unstructured":"Chamberlain JM, Okada P, Holsti M, Mahajan P, Brown KM, Vance C, et al. Lorazepam vs diazepam for pediatric status epilepticus: a randomized clinical trial. JAMA. 2014;311(16):1652\u201360. https:\/\/doi.org\/10.1001\/jama.2014.2625.","journal-title":"JAMA."},{"issue":"5","key":"5717_CR31","doi-asserted-by":"publisher","first-page":"426","DOI":"10.1136\/archdischild-2018-314924","volume":"104","author":"DP Inwald","year":"2018","unstructured":"Inwald DP, Canter R, Woolfall K, Mouncey P, Zenasni Z, O'Hara C, et al. Restricted fluid bolus volume in early septic shock: results of the Fluids in Shock pilot trial. Arch Dis Child. 2018;104(5):426\u201331. https:\/\/doi.org\/10.1136\/archdischild-2018-314924.","journal-title":"Arch Dis Child."},{"issue":"10186","key":"5717_CR32","doi-asserted-by":"publisher","first-page":"2135","DOI":"10.1016\/S0140-6736(19)30722-6","volume":"393","author":"SR Dalziel","year":"2019","unstructured":"Dalziel SR, Borland ML, Furyk J, Bonisch M, Neutze J, Donath S, et al. Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT): an open-label, multicentre, randomised controlled trial. Lancet. 2019;393(10186):2135\u201345. https:\/\/doi.org\/10.1016\/S0140-6736(19)30722-6.","journal-title":"Lancet."},{"issue":"1","key":"5717_CR33","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1177\/1740774517737318","volume":"15","author":"AN Haggins","year":"2018","unstructured":"Haggins AN, Harney D, Scott S, Silbergleit R. A systematic review of Federal Drug Administration Docket for community consultation and public disclosure in exception from informed consent trials. Clin Trials. 2018;15(1):29\u201335. https:\/\/doi.org\/10.1177\/1740774517737318.","journal-title":"Clin Trials."},{"key":"5717_CR34","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1016\/j.jss.2018.09.007","volume":"234","author":"JA Harvin","year":"2019","unstructured":"Harvin JA, Podbielski JM, Vincent LE, Liang MK, Kao LS, Wade CE, et al. Impact of Social Media on Community Consultation in Exception From Informed Consent Clinical Trials. J Surg Res. 2019;234:65\u201371. https:\/\/doi.org\/10.1016\/j.jss.2018.09.007.","journal-title":"J Surg Res."},{"issue":"4","key":"5717_CR35","doi-asserted-by":"publisher","first-page":"409","DOI":"10.1007\/s00134-018-5147-3","volume":"44","author":"N Van Regenmortel","year":"2018","unstructured":"Van Regenmortel N, Verbrugghe W, Roelant E, Van den Wyngaert T, Jorens PG. Maintenance fluid therapy and fluid creep impose more significant fluid, sodium, and chloride burdens than resuscitation fluids in critically ill patients: a retrospective study in a tertiary mixed ICU population. Intensive Care Med. 2018;44(4):409\u201317. https:\/\/doi.org\/10.1007\/s00134-018-5147-3.","journal-title":"Intensive Care Med."},{"key":"5717_CR36","doi-asserted-by":"crossref","unstructured":"Feld LG, Neuspiel DR, Foster BA, Leu MG, Garber MD, Austin K, et al. Clinical Practice Guideline: Maintenance Intravenous Fluids in Children. Pediatrics. 2018;142(6)","DOI":"10.1542\/peds.2018-3083"},{"issue":"2","key":"5717_CR37","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","volume":"42","author":"PA Harris","year":"2009","unstructured":"Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377\u201381. https:\/\/doi.org\/10.1016\/j.jbi.2008.08.010.","journal-title":"J Biomed Inform."},{"issue":"1-4","key":"5717_CR38","doi-asserted-by":"publisher","first-page":"89","DOI":"10.1159\/000363725","volume":"127","author":"FT Billings","year":"2014","unstructured":"Billings FT, Shaw AD. Clinical trial endpoints in acute kidney injury. Nephron Clin Pract. 2014;127(1-4):89\u201393. https:\/\/doi.org\/10.1159\/000363725.","journal-title":"Nephron Clin Pract."},{"issue":"5","key":"5717_CR39","doi-asserted-by":"publisher","first-page":"664","DOI":"10.2215\/CJN.12201018","volume":"14","author":"SL Weiss","year":"2019","unstructured":"Weiss SL, Balamuth F, Thurm CW, Downes KJ, Fitzgerald JC, Laskin BL. Major Adverse Kidney Events in Pediatric Sepsis. Clin J Am Soc Nephrol. 2019;14(5):664\u201372. https:\/\/doi.org\/10.2215\/CJN.12201018.","journal-title":"Clin J Am Soc Nephrol."},{"issue":"5","key":"5717_CR40","doi-asserted-by":"publisher","first-page":"844","DOI":"10.2215\/CJN.12791211","volume":"7","author":"PM Palevsky","year":"2012","unstructured":"Palevsky PM, Molitoris BA, Okusa MD, Levin A, Waikar SS, Wald R, et al. Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology. Clin J Am Soc Nephrol. 2012;7(5):844\u201350. https:\/\/doi.org\/10.2215\/CJN.12791211.","journal-title":"Clin J Am Soc Nephrol."},{"key":"5717_CR41","first-page":"207","volume":"C1","author":"KK Lan","year":"1982","unstructured":"Lan KK, Simon R, Halperin M. Stochastically curtailed tests in long-term clinical trials. Commun Stat Sequential Anal. 1982;C1:207\u201319.","journal-title":"Commun Stat Sequential Anal."},{"issue":"1","key":"5717_CR42","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1093\/biostatistics\/kxw030","volume":"18","author":"Y Benjamini","year":"2017","unstructured":"Benjamini Y, Cohen R. Weighted false discovery rate controlling procedures for clinical trials. Biostatistics. 2017;18(1):91\u2013104. https:\/\/doi.org\/10.1093\/biostatistics\/kxw030.","journal-title":"Biostatistics."},{"issue":"1-2","key":"5717_CR43","doi-asserted-by":"publisher","first-page":"279","DOI":"10.1016\/S0166-4328(01)00297-2","volume":"125","author":"Y Benjamini","year":"2001","unstructured":"Benjamini Y, Drai D, Elmer G, Kafkafi N, Golani I. Controlling the false discovery rate in behavior genetics research. Behav Brain Res. 2001;125(1-2):279\u201384. https:\/\/doi.org\/10.1016\/S0166-4328(01)00297-2.","journal-title":"Behav Brain Res."},{"issue":"4","key":"5717_CR44","doi-asserted-by":"publisher","first-page":"369","DOI":"10.1191\/0962280205sm403oa","volume":"14","author":"G Dunn","year":"2005","unstructured":"Dunn G, Maracy M, Tomenson B. Estimating treatment effects from randomized clinical trials with noncompliance and loss to follow-up: the role of instrumental variable methods. Stat Methods Med Res. 2005;14(4):369\u201395. https:\/\/doi.org\/10.1191\/0962280205sm403oa.","journal-title":"Stat Methods Med Res."},{"key":"5717_CR45","first-page":"5","volume":"32","author":"NE Breslow","year":"1980","unstructured":"Breslow NE, Day NE. Statistical methods in cancer research. Volume I - The analysis of case-control studies. IARC Sci Publ. 1980;32:5\u2013338.","journal-title":"Volume I - The analysis of case-control studies. IARC Sci Publ."},{"issue":"2","key":"5717_CR46","doi-asserted-by":"publisher","first-page":"1281","DOI":"10.1016\/j.jeconom.2007.02.002","volume":"141","author":"J Wooldridge","year":"2007","unstructured":"Wooldridge J. Inverse probability weighted estimation for general missing data problems. J Econometrics. 2007;141(2):1281\u2013301. https:\/\/doi.org\/10.1016\/j.jeconom.2007.02.002.","journal-title":"J Econometrics."},{"issue":"260","key":"5717_CR47","doi-asserted-by":"publisher","first-page":"663","DOI":"10.1080\/01621459.1952.10483446","volume":"47","author":"DG Horvitz","year":"1952","unstructured":"Horvitz DG, Thompson DJ. A generalization of sampling without replacement from a finite universe. J Am Stat Assoc. 1952;47(260):663\u201385. https:\/\/doi.org\/10.1080\/01621459.1952.10483446.","journal-title":"J Am Stat Assoc."},{"issue":"2","key":"5717_CR48","doi-asserted-by":"publisher","first-page":"217","DOI":"10.31887\/DCNS.2011.13.2\/npatsopoulos","volume":"13","author":"NA Patsopoulos","year":"2011","unstructured":"Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13(2):217\u201324. https:\/\/doi.org\/10.31887\/DCNS.2011.13.2\/npatsopoulos.","journal-title":"Dialogues Clin Neurosci."},{"issue":"2","key":"5717_CR49","doi-asserted-by":"publisher","first-page":"209","DOI":"10.31887\/DCNS.2011.13.2\/gtosh","volume":"13","author":"G Tosh","year":"2011","unstructured":"Tosh G, Soares-Weiser K, Adams CE. Pragmatic vs explanatory trials: the pragmascope tool to help measure differences in protocols of mental health randomized controlled trials. Dialogues Clin Neurosci. 2011;13(2):209\u201315. https:\/\/doi.org\/10.31887\/DCNS.2011.13.2\/gtosh.","journal-title":"Dialogues Clin Neurosci."},{"issue":"1","key":"5717_CR50","doi-asserted-by":"publisher","first-page":"260","DOI":"10.1378\/chest.117.1.260","volume":"117","author":"SM Forsythe","year":"2000","unstructured":"Forsythe SM, Schmidt GA. Sodium bicarbonate for the treatment of lactic acidosis. Chest. 2000;117(1):260\u20137. https:\/\/doi.org\/10.1378\/chest.117.1.260.","journal-title":"Chest."},{"issue":"10141","key":"5717_CR51","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1016\/S0140-6736(18)31080-8","volume":"392","author":"S Jaber","year":"2018","unstructured":"Jaber S, Paugam C, Futier E, Lefrant JY, Lasocki S, Lescot T, et al. Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): a multicentre, open-label, randomised controlled, phase 3 trial. Lancet. 2018;392(10141):31\u201340. https:\/\/doi.org\/10.1016\/S0140-6736(18)31080-8.","journal-title":"Lancet."},{"issue":"10","key":"5717_CR52","doi-asserted-by":"publisher","first-page":"1169","DOI":"10.1111\/acem.13438","volume":"25","author":"L Klein","year":"2018","unstructured":"Klein L, Moore J, Biros M. A 20-year Review: The Use of Exception From Informed Consent and Waiver of Informed Consent in Emergency Research. Acad Emerg Med. 2018;25(10):1169\u201377. https:\/\/doi.org\/10.1111\/acem.13438.","journal-title":"Acad Emerg Med."}],"updated-by":[{"DOI":"10.1186\/s13063-025-09164-3","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T00:00:00Z","timestamp":1759795200000}}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05717-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-021-05717-4","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05717-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T18:02:11Z","timestamp":1768586531000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s13063-021-05717-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,11,6]]},"references-count":52,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2021,12]]}},"alternative-id":["5717"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05717-4","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,11,6]]},"assertion":[{"value":"25 May 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 October 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 November 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 October 2025","order":5,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":6,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":7,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1186\/s13063-025-09164-3","URL":"https:\/\/doi.org\/10.1186\/s13063-025-09164-3","order":8,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"A single Institutional Review Board at The Children's Hospital of Philadelphia is providing regulatory oversight for all US study sites (IRB #19-016484). In Canada, the University of Calgary will sponsor regulatory approval through Health Canada, while each site\u2019s Research Ethics Board will oversee local human subjects\u2019 protections, except sites in Ontario, for which centralized approval through Clinical Trials Ontario will be obtained (pending). A single ethics committee at The Royal Children\u2019s Hospital Melbourne is providing regulatory oversight for Australia study sites (#68569). In New Zealand, a single ethics committee will provide regulatory oversight (pending).Prospective written informed consent will be sought from a legally authorized representative (LAR, e.g., at least one parent) prior to enrollment when sufficient time permits. Alternatively, enrollment may proceed in the US under the federal \u201cException From Informed Consent\u201d (EFIC, 21 CFR 50.24) for emergency research and in Canada and Australia\/New Zealand with \u201cdeferred consent\u201d in compliance with the Canadian Tri-Council Policy Statement-2 and National Statement on Ethical Conduct in Human Research, respectively. A waiver of assent will be requested due to the critical nature of illness in septic shock.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"776"}}