Saline Versus Balanced Crystalloid in Traumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville
About this trial
The goal of this clinical trial is to determine which crystalloid (saline or balanced) should be used in the critical management of Traumatic Brain Injury (TBI) in moderate or severe TBI patients. This trial will determine whether the use of saline or balanced crystalloids is associated with improved outcomes in TBI patients.
Participants will
1. be given fluids through the veins, either saline or balanced fluid will be given. 2. From the first day to the day 14 of the hospitalization (or discharge, whichever comes first), vital signs, laboratory values, treatments given, and other medical data will be collected from the medical record. 3. Six months later, your final disability, if any, will be assessed during your follow-up with a doctor. It involves answering a short survey that will take about 5 minutes or less.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Trauma patients presenting to the Emergency Room for initial care
Glasgow Coma Scale ≤ 12
Head CT with skull fracture(s) and/or hemorrhage(s) (>1cm in any single dimension) with a reported mechanism of trauma
Disqualifiers
Severe visceral trauma dictating mortality (visceral injury severity score > brain injury severity score)
Non-survivable brain injury based on the treating physician's judgment
Emergent visceral operative intervention before complete trauma assessment
Concern for ruptured intracranial vascular malformation
Trial design
Design model
Parallel
Treatments tested in this trial
Normal Saline (0.9% NaCl)
DrugFor the primary purpose of fluid therapy or resuscitation in the emergency room and during hospitalization. The interventions will be administered intravenously whenever isotonic intravenous fluid administration is ordered by the treating provider for fluid resuscitation and/or maintenance in the emergency room and during inpatient hospitalization. Assignment to the intervention arm will be adhered to from enrollment to discharge. The total volume, rate, initiation, cessation, and co-interventions will be left to the discretion of the treating provider. Adherence will be ensured by dual interventions at the level of pharmacy IV fluid supply and physician order. The fluids will be physically administered according to the standard intravenous procedures and those outlined in the manufacturer's instructions.
balanced crystalloid
DrugFor the primary purpose of fluid therapy or resuscitation in the emergency room and during hospitalization. The interventions will be administered intravenously whenever isotonic intravenous fluid administration is ordered by the treating provider for fluid resuscitation and/or maintenance in the emergency room and during inpatient hospitalization. Assignment to the intervention arm will be adhered to from enrollment to discharge. The total volume, rate, initiation, cessation, and co-interventions will be left to the discretion of the treating provider. Adherence will be ensured by dual interventions at the level of pharmacy IV fluid supply and physician order. The fluids will be physically administered according to the standard intravenous procedures and those outlined in the manufacturer's instructions.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Normal SalineExperimental treatment 1 intervention
Group B: Isotonic CrystalloidActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neurological Outcomes
Glasgow Outcome Scale-Extended (GOSE) 8-point scale. Glasgow Outcome Scale has been widely accepted as the standard assessment scale of global outcomes after severe brain injury because it captures well how the injury affects functioning in major areas of life. Using the manual for the GOSE interview, we will conduct our primary efficacy assessment at 6 months after ICU admission in person or over the phone. Outcomes on the GOSE scale do not change past the 6-month mark in moderate and severe TBI patients. The 8-point ordinal GOSE scale for the primary efficacy assessment will be dichotomized into favorable (GOSE score 4-8) and unfavorable (GOSE 1-3) outcomes. The primary analysis model will be a logistic regression model where the outcome of interest is the dichotomized GOS-E evaluated at 6 months to reflect favorable and unfavorable outcomes. The covariate of interest is a randomization assignment.
Time frame
6 months post injurySecondary outcomes
1
Inpatient mortality
We will assess the inpatient mortality of the participants. We will note the time from admission to death or discharge. The secondary outcome (inpatient mortality) will be analyzed using two approaches. The primary analysis model will be a logistic regression model where the outcome of interest is the vitality status (alive or dead) at discharge. The covariate of interest is a randomization assignment. The secondary analysis will be a time-to-death analysis comparing the survival curves between the two randomized groups using a log-rank test.
Time frame
randomization to hospital discharge typically 2 weeks.Other outcomes
1
To compare delayed interventions to treat Intracranial pressure (ICP).
Surgical or medical ICP-related therapeutic interventions. Events of acute kidney injury, cerebral edema, and in-patient mortality, will be captured.
Time frame
randomization to hospital discharge, typically 2 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Louisville
Lead sponsor
Kentucky Spinal Cord and Head Injury Research Board
Collaborator
Source ClinicalTrials.gov