Saline Versus Balanced Crystalloid in Traumatic Brain Injury (FLUID-TBI)

University of Louisville (UOFL)

Status and phase: Enrolling; Phase 3

Conditions: Traumatic Brain Injury (TBI) Patients

Treatments: Drug: balanced crystalloid; Drug: Normal Saline (0.9% NaCl)

Study type: Interventional

Funder types: Other

Identifiers

NCT06953674

24.0224

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Normal Saline

Experimental group

Description:

normal saline (0.9% sodium chloride) administered intravenously

Treatment:

Drug: Normal Saline (0.9% NaCl)

Isotonic Crystalloid

Active Comparator group

Description:

balanced crystalloid intravenous fluid therapy

Treatment:

Drug: balanced crystalloid