Saline vs. Balanced Crystalloid in Traumatic Brain Injury
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Neurological Outcomes
研究概览
简要总结
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
- be given fluids through the veins, either saline or balanced fluid will be given.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Normal Saline
normal saline (0.9% sodium chloride) administered intravenously
干预措施: Normal Saline (0.9% NaCl) (Drug)
Isotonic Crystalloid
balanced crystalloid intravenous fluid therapy
干预措施: balanced crystalloid (Drug)
结局指标
主要结局
Neurological Outcomes
时间窗: 6 months post injury
Glasgow Outcome Scale-Extended (GOSE) 8-point scale. Glasgow Outcome Scale has been widely accepted as the standard assessment scale of global outcomes after severe brain injury because it captures well how the injury affects functioning in major areas of life. Using the manual for the GOSE interview, we will conduct our primary efficacy assessment at 6 months after ICU admission in person or over the phone. Outcomes on the GOSE scale do not change past the 6-month mark in moderate and severe TBI patients. The 8-point ordinal GOSE scale for the primary efficacy assessment will be dichotomized into favorable (GOSE score 4-8) and unfavorable (GOSE 1-3) outcomes. The primary analysis model will be a logistic regression model where the outcome of interest is the dichotomized GOS-E evaluated at 6 months to reflect favorable and unfavorable outcomes. The covariate of interest is a randomization assignment.
次要结局
- Inpatient mortality(randomization to hospital discharge typically 2 weeks.)
研究者
Akshitkumar MIstry
Assistant Professor Term
University of Louisville