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Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Study acronym: FLUID-TBI
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2025 to Jun 1, 2025
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06953674
Lead Sponsor University of Louisville
Collaborators: Kentucky Spinal Cord and Head Injury Research Board
Conditions
(from sponsor)		 Traumatic Brain Injury (TBI) Patients
Related terms Brain Injuries, Traumatic
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov