Recruiting
Phase 3

Saline vs. Balanced Crystalloids

Sponsor:

University of Louisville

Code:

NCT06953674

Conditions

Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Normal Saline (0.9% NaCl)

balanced crystalloid

Study Details

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.

Conditions

Traumatic Brain Injury (TBI) Patients

Study ID

NCT06953674

Start date

Jun 1, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Normal Saline

normal saline (0.9% sodium chloride) administered intravenously

active comparator: Isotonic Crystalloid

balanced crystalloid intravenous fluid therapy

Interventions

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.

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.

Primary outcome measure

  • Neurological Outcomes [ Time Frame: 6 months post injury ]

Central Contacts and Locations

Central contacts

Mechelle Kaufman, BSN, RN

502-588-2329mechelle.kaufman@louisville.edu

Akshitkumar Mistry, M.D.

a.mistry@uoflhealth.org

Locations

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Mechelle Kaufman, BSN

502-852-5992mechelle.kaufman@louisville.edu

More Information

Sponsor

University of Louisville

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2026-08-26.