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However, the optimal type of crystalloid fluid is unknown. We aimed to determine the feasibility of conducting a pragmatic randomized trial to compare balanced (lactated Ringer's [<jats:styled-content style=\"fixed-case\">LR<\/jats:styled-content>]) with 0.9% normal saline (<jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>) fluid resuscitation in children with suspected septic shock.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Open\u2010label pragmatic randomized controlled trial at a single academic children's hospital from January to August 2018. Eligible patients were\u00a0&gt;6 months to\u00a0&lt;18 years old who were treated in the emergency department for suspected septic shock, operationalized as blood culture, parenteral antibiotics, and fluid resuscitation for abnormal perfusion. Screening, enrollment, and randomization were carried out by the clinical team as part of routine care. Patients were randomized to receive either <jats:styled-content style=\"fixed-case\">LR<\/jats:styled-content> or <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content> for up to 48 hours following randomization. Other than fluid type, all treatment decisions were at the clinical team's discretion. Feasibility outcomes included proportion of eligible patients enrolled, acceptability of enrollment via the U.S. federal exception from informed consent (<jats:styled-content style=\"fixed-case\">EFIC<\/jats:styled-content>) regulations, and adherence to randomized study fluid administration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 59 eligible patients, 50 (85%) were enrolled and randomized. Twenty\u2010four were randomized to <jats:styled-content style=\"fixed-case\">LR<\/jats:styled-content> and 26 to <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>. Only one (2%) of 44 patients enrolled using <jats:styled-content style=\"fixed-case\">EFIC<\/jats:styled-content> withdrew before study completion. Total median (interquartile range [<jats:styled-content style=\"fixed-case\">IQR<\/jats:styled-content>]) crystalloid fluid volume received during the intervention window was 107 (60 to 155) <jats:styled-content style=\"fixed-case\">mL<\/jats:styled-content>\/kg and 98 (63 to 128) <jats:styled-content style=\"fixed-case\">mL<\/jats:styled-content>\/kg in the <jats:styled-content style=\"fixed-case\">LR<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content> arms, respectively (p\u00a0=\u00a00.50). Patients randomized to <jats:styled-content style=\"fixed-case\">LR<\/jats:styled-content> received a median (<jats:styled-content style=\"fixed-case\">IQR<\/jats:styled-content>) of only 20% (13 to 32) of all study fluid as <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content> compared to 99% (64% to 100%) of study fluid as <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content> in the <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content> arm (absolute difference\u00a0= 79%, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\u00a0= 48% to 85%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>A pragmatic study design proved feasible to study comparative effectiveness of <jats:styled-content style=\"fixed-case\">LR<\/jats:styled-content> versus <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content> fluid resuscitation for pediatric septic shock.<\/jats:p><\/jats:sec>","DOI":"10.1111\/acem.13815","type":"journal-article","created":{"date-parts":[[2019,6,11]],"date-time":"2019-06-11T06:28:55Z","timestamp":1560234535000},"page":"1346-1356","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":43,"title":["Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: The <scp>PR<\/scp>o<scp>MPT BOLUS<\/scp> Randomized Controlled Trial Pilot Feasibility Study"],"prefix":"10.1111","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3709-7160","authenticated-orcid":false,"given":"Fran","family":"Balamuth","sequence":"first","affiliation":[{"name":"Department of Pediatrics Division of Emergency Medicine Children's Hospital of Philadelphia University of Pennsylvania Perelman School of Medicine Philadelphia PA"},{"name":"Pediatric Sepsis Program Children's Hospital of Philadelphia University of Pennsylvania Perelman School of Medicine Philadelphia PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlena","family":"Kittick","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Division of Emergency Medicine Children's Hospital of Philadelphia University of Pennsylvania Perelman School of Medicine Philadelphia PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"McBride","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Division of Emergency Medicine Children's Hospital of Philadelphia University of Pennsylvania Perelman School of Medicine Philadelphia PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley L.","family":"Woodford","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Division of Emergency Medicine Children's Hospital of Philadelphia University of Pennsylvania Perelman School of Medicine Philadelphia PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Vestal","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Division of Emergency Medicine Children's Hospital of Philadelphia University of Pennsylvania Perelman School of Medicine Philadelphia PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T. 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