10.6084/M9.FIGSHARE.C.6225364.V1
Jizhe Zhang
Jizhe
Zhang
0000-0001-8269-1885
Third Affiliated Hospital of Southern Medical University
Key Laboratory of Guangdong Province
Dong Han
Dong
Han
Third Affiliated Hospital of Southern Medical University
Kun Zhang
Kun
Zhang
Third Affiliated Hospital of Southern Medical University
Key Laboratory of Guangdong Province
Weiqiang Guan
Weiqiang
Guan
Third Affiliated Hospital of Southern Medical University
Key Laboratory of Guangdong Province
Li Li
Li
Li
0000-0001-5889-8667
Third Affiliated Hospital of Southern Medical University
Key Laboratory of Guangdong Province
Zhengtao Gu
Zhengtao
Gu
0000-0001-8566-6634
Third Affiliated Hospital of Southern Medical University
Key Laboratory of Guangdong Province
Observation on the effectiveness and safety of sodium bicarbonate Ringer’s solution in the early resuscitation of traumatic hemorrhagic shock: a clinical single-center prospective randomized controlled trial
Abstract Background 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 h of resuscitation, complications, and 7-day survival in patients with THS. Methods /design. 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’s solution (control group) until successful resuscitation from THS. Lactate clearance at different time points (0.5, 1, 1.5, 3, and 6 h) 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 days after discharge. Discussion 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. Trial registration. Chinese Clinical Trial Registry (ChiCTR), ChiCTR2100045044. Registered on 4 April 2021.
Medicine
Infectious Diseases
Virology
Computational Biology
figshare
2022
2022-09-30
2022-09-30
Collection
10.6084/m9.figshare.c.6225364
CC BY 4.0