RECRUITING

Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Description

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.

Study Overview

Study Details

Study overview

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.

Saline vs. Balanced Crystalloid in Traumatic Brain Injury

Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Condition
Traumatic Brain Injury (TBI) Patients
Intervention / Treatment

-

Contacts and Locations

Louisville

University of Louisville Hospital, Louisville, Kentucky, United States, 40202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Louisville,

Akshitkumar Mistry, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor Term

Study Record Dates

2029-09