Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 389
- 试验地点
- 2
- 主要终点
- Number of Participants With Death or Poor Neurologic Outcome at 6 Months
研究概览
简要总结
This trial is currently a single-center, randomized, double-blind investigator initiated prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI). The plan is to expand the trial shortly as a multi-center project. The patients for this study will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (OHCA). The aim of this study is to determine whether neurologic outcomes at six months are improved with moderate (31 degrees Celsius) versus mild (34 degrees Celsius) therapeutic hypothermia (TH) following return of spontaneous circulation (ROSC) in patients suffering OHCA, with ROSC defined as the resumption of sustained perfusing cardiac activity.
The primary outcome will be the proportion of patients experiencing death or a poor neurologic outcome at six months after out of hospital cardiac arrest.
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
- Double (Participant, 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
- •Out of hospital cardiac arrest patient
- •Return of spontaneous circulation
- •Glasgow Coma Score equal or lesser than 8.
排除标准
- •Patients residing in a Nursing Home or patients unable to reside independently,
- •Intracranial bleed responsible for the cardiac arrest,
- •Severe coagulopathy with clinical evidence of major bleeding,
- •Coma that is not attributable to cardiac arrest,
- •Life expectancy of < one year due to any cause unrelated to the cardiac arrest,
- •Known coagulation disorder (i.e. INR >2.0, platelets <100,000 / mm3),
- •Participation in a study with another investigational device or drug < four weeks,
- •The Endovascular cooling (ZOLL) device is not available.
结局指标
主要结局
Number of Participants With Death or Poor Neurologic Outcome at 6 Months
时间窗: Six months
The primary outcome of the study will be death or poor neurologic outcome at six months. Neurologic outcome will be assessed by a specialist in rehabilitation medicine using the Disability Ratings Scale (DRS. Patients will be judged to have had a poor neurologic outcome if the score on the DRS scale is \>5.
次要结局
- Number of Mortality(30 days and 6 months)
- Number of Participants With Stroke(30 days and 6 months)
- Number of Participants With Bleeding(During index hospitalization, up to 40 days)
- Length of Stay in the Unit(Admission to unit to discharge from unit)
- Length of Stay in the Hospital(Admission to hospital to discharge from hospital.)
- Number of Participants With Cardiogenic Shock(During index hospitalization - day of admission to day of discharge from the facility (*up to 30 days post admission))
- Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR)(Six months)
- Number of Participants With Seizures(During index hospitalization (*up to 45 days post admission day while in hospital))
- Number of Participants With Renal Failure Requiring Renal Replacement Therapy(During index hospitalization - day of admission up to 45 days post admission while in hospital)
- Number of Participants With Ventilator Associated Pneumonia(During index hospitalization - from day of admission up to 45 days post admission (while in hospital))
- Number of Participants With Stent Thrombosis(Within 6 months of their admission)
- Number of Participants Discharged Home(Six months)