Saline Versus Balanced Crystalloid in Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Interventions
- Drug: Normal Saline (0.9% NaCl)Drug: balanced crystalloid
- Registration Number
- NCT06953674
- Lead Sponsor
- University of Louisville
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
- 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
- Patients who are transferred from another facility
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal Saline Normal Saline (0.9% NaCl) normal saline (0.9% sodium chloride) administered intravenously Isotonic Crystalloid balanced crystalloid balanced crystalloid intravenous fluid therapy
- Primary Outcome Measures
Name Time Method Neurological Outcomes 6 months post injury 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.
- Secondary Outcome Measures
Name Time Method Inpatient mortality randomization to hospital discharge typically 2 weeks. 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.