Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Coenzyme Q10 Plasma Levels
研究概览
简要总结
To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest.
详细描述
Cardiac arrest (CA) occurs in more than 400,000 patients in the United States each year with an estimated mortality of greater than 90%. The majority of patients who are resuscitated from CA will succumb to the neurologic morbidity associated with the post-CA syndrome and ischemic-reperfusion injury. Currently, there are no pharmacologic agents known to offer survival benefit or to prevent devastating neurologic injury in post-CA patients.
A potential therapeutic target following ischemia-reperfusion injury is mitochondrial function in the injured cell and/or reduction of oxygen free radicals. Coenzyme Q10 (CoQ10) is an essential mitochondrial co-factor and free radical scavenger that has been proposed as a neuroprotective agent in various neurodegenerative disorders as well as a cardioprotective agent. CoQ10 have furthermore shown exciting preliminary results as a potential therapy in post-CA.
In order to test the effects of ubiquinol as a "metabolic resuscitator" in post-CA patients and to provide additional preliminary data for a large-scale clinical trial, the investigators are conducting a randomized, double-blind, place-controlled trial of ubiquinol in post-CA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Adult (≥ 18 years)
- •Cardiac arrest defined by cessation of pulse requiring chest compressions
- •Not following commands after ROSC
- •Admission to the ICU
- •Naso/orogastric tube
- •Ability to receive enteral medication
排除标准
- •Protected populations (pregnant women, prisoners, the intellectual disabled)
- •Current CoQ10 supplementation
- •Anticipated death within 24 hours
- •> 12 hours from ROSC to estimated randomization
- •Jejunostomy tube (J-tube)
研究组 & 干预措施
Control
Patients in the control group will receive a liquid placebo, which is 50 mL of Ensure (a dietary supplement). This will be given every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
干预措施: Ensure (Dietary Supplement)
Ubiquinol
Patients in the experimental group will receive 300 mg of Ubiquinol in a liquid mixture. The liquid Ubiquinol will be mixed with 50 mL of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
干预措施: Ubiquinol (Drug)
Ubiquinol
Patients in the experimental group will receive 300 mg of Ubiquinol in a liquid mixture. The liquid Ubiquinol will be mixed with 50 mL of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days, until neurologic recovery, or until hospital discharge.
干预措施: Ensure (Dietary Supplement)
结局指标
主要结局
Coenzyme Q10 Plasma Levels
时间窗: Up to 72 hours
Total (oxidized and reduced form) coenzyme Q10
次要结局
- Global Oxygen Consumption(Up to 48 hours)
- Mortality(At hospital discharge, an average of 14 days)
- Cellular Oxygen Consumption(At 24 hours)
- Decreased Neurological Injury(Up to 72 hours)
- Number of Participants With Favorable Neurological Outcome(At hospital discharge, an average of 14 days)
研究者
Michael Donnino
MD
Beth Israel Deaconess Medical Center