Saline Versus Balanced Crystalloid in Traumatic Brain Injury

PHASE3RecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

June 30, 2029

Study Completion Date

September 30, 2029

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.

Trial Locations (1)

40202

RECRUITING

University of Louisville Hospital, Louisville

All Listed Sponsors
collaborator

Kentucky Spinal Cord and Head Injury Research Board

UNKNOWN

lead

University of Louisville

OTHER