Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mortality within 30 days
研究概览
简要总结
Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed preliminary mechanistic analysis of alternative fuels in humans and have demonstrated proof of concept that exogenous fuels alter brain metabolism. We will conduct a multicenter, adaptive design-based, proof of concept phase 2 safety study of candidate supplemental fuels in patients with severe traumatic brain injury to determine safety and efficacy.
详细描述
Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed safety analysis of exogenous sodium lactate infusions in humans and have demonstrated proof of concept that these fuels alter brain metabolism. Animal TBI studies have demonstrated proof of concept for exogenous lactate and pyruvate. We will conduct a multicenter, adaptive design-based, proof of concept biomarker mechanistic safety study of exogenous sodium lactate. The preliminary goal is to determine if exogenous lactate infusion is safe and has a demonstrated effect on selected biomarkers.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Adult patients seen in the Medical Center Emergency Department
- •Adult patients transferred to the Neurocritical Intensive Care Unit with a physician's diagnosis of brain injury.
排除标准
- •Pregnancy at time of injury
- •History of diabetes mellitus
- •History of hemodynamic instability
- •Known terminal illness which alters brain functioning
- •Diagnosed AIDS progressed to AIDS dementia
- •Known history of chronic severe neurological disturbance
- •Severe retardation
- •Previous severe diminished mental capacity
- •No command of either English or Spanish
- •Arrest for a felony
- •Active neurologic condition such as stroke, recent TBI
- •metabolic disorder
- •preexisting hyperlactatemia
- •instability precluding experimental intervention
研究组 & 干预措施
ELI Arm
Infusion of exogenous sodium lactate as supplemental fuel within 48 hours of TBI
干预措施: Sodium Lactate (Drug)
Placebo
Placebo infusion of normal saline in Part 2 RCT
干预措施: Placebo (Drug)
结局指标
主要结局
Mortality within 30 days
时间窗: 30 days
Percentage mortality within 30 days
次要结局
未报告次要终点
研究者
Paul Vespa, MD
Professor
University of California, Los Angeles