{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T13:44:05Z","timestamp":1781271845219,"version":"3.54.1"},"reference-count":42,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,9,30]],"date-time":"2022-09-30T00:00:00Z","timestamp":1664496000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,9,30]],"date-time":"2022-09-30T00:00:00Z","timestamp":1664496000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Traumatic hemorrhagic shock (THS) is the main cause of death in trauma patients with high mortality. Rapid control of the source of bleeding and early resuscitation are crucial to clinical treatment. Guidelines recommend isotonic crystal resuscitation when blood products are not immediately available. However, the selection of isotonic crystals has been controversial. Sodium bicarbonate Ringer solutions (BRS), containing sodium bicarbonate, electrolyte levels, and osmotic pressures closer to plasma, are ideal. Therefore, in this study, we will focus on the effects of BRS on the first 6\u00a0h of resuscitation, complications, and 7-day survival in patients with THS.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>\/design.<\/jats:p>\n                <jats:p>This single-center, prospective, randomized controlled trial will focus on the efficacy and safety of BRS in early THS resuscitation. A total of 400 adults THS patients will be enrolled in this study. In addition to providing standard care, enrolled patients will be randomized in a 1:1 ratio to receive resuscitation with BRS (test group) or sodium lactate Ringer\u2019s solution (control group) until successful resuscitation from THS. Lactate clearance at different time points (0.5, 1, 1.5, 3, and 6\u00a0h) and shock duration after drug administration will be compared between the two groups as primary end points. Secondary end points will compare coagulation function, temperature, acidosis, inflammatory mediator levels, recurrence of shock, complications, medication use, and 7-day mortality between the two groups. Patients will be followed up until discharge or 7\u00a0days after discharge.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>At present, there are still great differences in the selection of resuscitation fluids, and there is a lack of systematic and detailed studies to compare and observe the effects of various resuscitation fluids on the effectiveness and safety of early resuscitation in THS patients. This trial will provide important clinical data for resuscitation fluid selection and exploration of safe dose of BRS in THS patients.<\/jats:p>\n                <jats:p>Trial registration.<\/jats:p>\n                <jats:p>Chinese Clinical Trial Registry (ChiCTR), ChiCTR2100045044. Registered on 4 April 2021.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-022-06752-5","type":"journal-article","created":{"date-parts":[[2022,9,29]],"date-time":"2022-09-29T23:04:02Z","timestamp":1664492642000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Observation on the effectiveness and safety of sodium bicarbonate Ringer\u2019s solution in the early resuscitation of traumatic hemorrhagic shock: a clinical single-center prospective randomized controlled trial"],"prefix":"10.1186","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8269-1885","authenticated-orcid":false,"given":"Jizhe","family":"Zhang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong","family":"Han","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kun","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weiqiang","family":"Guan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5889-8667","authenticated-orcid":false,"given":"Li","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8566-6634","authenticated-orcid":false,"given":"Zhengtao","family":"Gu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,9,30]]},"reference":[{"issue":"1","key":"6752_CR1","doi-asserted-by":"publisher","first-page":"98","DOI":"10.1186\/s13054-019-2347-3","volume":"23","author":"DR Spahn","year":"2019","unstructured":"Spahn DR, Bouillon B, Cerny V, Duranteau J, Filipescu D, Hunt BJ, et al. 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Reference number: ChiECRCT20210137.Investigators have all obtained ethics approval before being allowed to conduct and participate in the study.As injuries are accidental, according to the eligibility criteria, all subjects are incapacitated. Therefore, subjects will not be able to provide informed consent. This study requires the intervention to be carried out rapidly, so it is necessary to enroll eligible patients in the trial as soon as possible after admission. The trial will be conducted in accordance with the Declaration of Helsinki and will follow national legislation on medical research in subjects temporarily incapacitated in emergency situations. In this trial, an investigator who is not involved in the subject\u2019s treatment will be required to obtain guardian consent as early as possible prior to the subject\u2019s inclusion in the study. If a patient\u2019s guardian is present, information about the trial will be provided to them in writing. If the guardian objects, their wishes will be respected. If subjects regain physical and mental capacity to consent, they will be provided with information and wrote informed consent will be sought to proceed with the trial. For any patient who is enrolled but does not regain full capacity, guardian consent will be sought to continue the trial. If the patient or guardian declines consent\/consent to continue at this stage, their wishes will be respected. All interactions and attempts to contact the guardian and\/or subject will be recorded in the study consent log.","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":"825"}}