Saline Versus Balanced Crystalloid in Traumatic Brain Injury

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.

Conditions

• Traumatic Brain Injury (TBI) Patients

Interventions

DRUG

Normal Saline (0.9% NaCl)

For 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.

DRUG

balanced crystalloid

For 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.

Sponsors & Collaborators

• Kentucky Spinal Cord and Head Injury Research Board

  collaborator UNKNOWN

• University of Louisville

  lead OTHER

Principal Investigators

• Akshitkumar Mistry, MD · Assistant Professor Term

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2029-06-30

Completion

2029-09-30

FDA Drug

Yes

Countries

• United States

Study Locations