Thiamine as a Metabolic Resuscitator After Cardiac Arrest
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Lactate
研究概览
简要总结
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA). .
详细描述
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA). Patients who have sustained return of spontaneous circulation (ROSC) after OHCA and have a lactate of 3 or greater will be eligible for the study. Enrolled patients will be randomized to intravenous thiamine 500mg twice daily for 5 doses or matching placebo (100cc normal saline). Blood will be drawn at several time points and patients will be connected to a noninvasive monitor for continuous measurement of global oxygen consumption. The primary endpoint is change in lactate level. Secondary endpoints include change in pyruvate dehydrogenase activity, change in cellular and global oxygen consumption, change in NSE and S100 (biomarkers of neurologic injury) and CPC-E score (a score that assesses neurologic and functional impairment) at hospital discharge, 30 and 90 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A randomization list was prepared by an independent statistician using 1:1 randomization in blocks of four. This list will be provided to the research pharmacy, and the research pharmacy will be the only unblinded people involved with the study, and will have no patient contact or role in the analysis or other aspects of the study. Thiamine is colorless and odorless, and the 500mg dose is mixed in 100mL of normal saline. Placebo will be 100mL of normal saline and is indistinguishable in appearance from thiamine. Study team, clinical team and patient and family will all be blind to the allocation.
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 patient (age ≥ 18 years)
- •Cardiac arrest occurring with sustained (> 20 minutes) return of spontaneous circulation (ROSC)
- •Within 4.5 hours of cardiac arrest event
- •Lactate >/=3
排除标准
- •Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
- •Traumatic etiology of arrest
- •Comfort measures only or anticipated withdrawal of support within 24 hours
- •Protected populations (pregnant women, prisoners)
- •Known allergy to thiamine
研究组 & 干预措施
Thiamine
Patients randomized to the thiamine arm will receive thiamine 500mg in 100mL of normal saline intravenously every 12 hours for 5 doses. Patients will be connected to a noninvasive monitor for measurement of global oxygen consumption (VO2) for at least 48 hours or until extubated, whichever comes first. Blood will be drawn at 0,6,12,24,72 and 168 hours for measurement of lactate, thiamine level, pyruvate dehydrogenase, NSE, S100 and other markers of organ injury. CPC-E score will be assessed prior to hospital discharge and at 30 and 90 days to evaluate differences in neurologic and functional impairment.
干预措施: Thiamine 500 mg IV (Drug)
Placebo
Patients randomized to placebo will receive 100mL normal saline intravenously every 12 hours for 5 doses. All other aspects of the protocol will be the same as in the experimental arm. Patients will be connected to a noninvasive monitor for measurement of global oxygen consumption (VO2) for at least 48 hours or until extubated, whichever comes first. Blood will be drawn at 0,6,12,24,72 and 168 hours for measurement of lactate, thiamine level, pyruvate dehydrogenase, NSE, S100 and other markers of organ injury. CPC-E score will be assessed prior to hospital discharge and at 30 and 90 days to evaluate differences in neurologic and functional impairment.
干预措施: Placebo (Other)
结局指标
主要结局
Lactate
时间窗: 24 hours
Blood Lactate Over Time
次要结局
- Lactate(72 hours)
- Pyruvate Dehydrogenase (PDH) Specific Activity(72 hours)
- Pyruvate Dehydrogenase (PDH) Activity(72 hours)
- Pyruvate Dehydrogenase (PDH) Quantity(72 hours)
- Mortality(will be assessed at hospital discharge and up to 30 and 90 days.)
- Favorable Cerebral Performance Category (CPC)(will be assessed up to 30 and 90 days)
- Sequential Organ Failure Assessment (SOFA) Score(over 72 hours)
- Acute Renal Failure(First 7 days following Arrest)
- Cellular Oxygen Consumption(0 hours and 24 hours.)
- Creatinine(72 hours)
- Biomarkers of Neurologic Injury(various time points over 7 days)
- Global Oxygen Consumption(48 hours)
研究者
Michael Donnino
Associate Professor of Medicine and Emergency Medicine
Beth Israel Deaconess Medical Center