Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT06953674
Phase
PHASE3
Status
Recruiting
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Conditions

  • Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Normal Saline (0.9% NaCl) — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Normal Saline
    normal saline (0.9% sodium chloride) administered intravenously
  • Active Comparator: Isotonic Crystalloid
    balanced crystalloid intravenous fluid therapy

Primary Outcome Measure

Neurological Outcomes [ Time Frame: 6 months post injury ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Louisville HospitalLouisvilleKentucky40202
Mechelle Kaufman, BSN
[email protected]
502-852-5992
Akshitkumar [email protected], M.D.

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By research site
University of Louisville Hospital· Louisville, KY

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