Pilot Randomized Clinical Trial Comparing the Efficacy of Two Different Hypothermia Temperatures for Treatment of Comatose Patients Recovered From an Out-of-hospital Cardiac Arrest
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Survival free from severe dependence (Barthel index <60)
研究概览
简要总结
Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is suggested with less evidence for asystole as first rhythm after cardiac arrest. The purpose of this study is to determine whether different temperature targets (32º vs 34º) may have different efficacy in the treatment of post-cardiac arrest patients. If successful, this pilot study will eventually form the basis for a larger, multicentric randomized clinical trial.
详细描述
Patients admitted consecutively were potentially eligible for the study if they had a witnessed out-off hospital cardiac arrest (OHCA) apparently related to heart disease and an interval of <60 minutes from collapse to return of spontaneous circulation (ROSC). Additional inclusion criteria were:
- Age >18 years.
- Initial registered rhythm of a shockable rhythm (ventricular fibrillation or pulseless ventricular tachycardia) or asystole.
Exclusion criteria were:
- Known pregnancy
- Glasgow Coma Scale score after ROSC >8.
- Cardiogenic shock (a systolic blood pressure of <80 mm Hg despite inotrope infusion >30 minutes).
- Other nonshockable rhythms (pulseless electric activity).
- Terminal illness present before the OHCA.
- Possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident).
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 (Participant)
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
- •Age > 18
- •Resuscitated patients from a cardiac arrest with first rhythm of ventricular fibrillation or asystole
- •Witnessed cardiac arrest
- •Estimated delay between cardiac arrest and advanced resuscitation < 20 min.
- •Resuscitation time from first contact to recovery of spontaneous circulation < 60 min.
- •Hemodynamic stability (Mean blood pressure [BP] >60 mmHg), with or without inotropic drugs, before randomization
- •Glasgow coma score <9 without sedation before randomization
排除标准
- •Pregnant women or suspected pregnancy or fertile women without a negative pregnancy test
- •Suspected non-cardiac arrest caused coma
- •Electrical instability (uncontrollable life-threatening arrhythmias)
- •Hemodynamic instability (Mean BP ≤60 mmHg), refractory to volume infusion or inotropic drugs
- •Refractory hypoxemia (saturation <85% with FiO2=100%)
- •Previous known terminal illness
- •Active bleeding or known coagulopathy
- •Opposition from patient's family to enter the study
结局指标
主要结局
Survival free from severe dependence (Barthel index <60)
时间窗: 6 months
次要结局
- Survival at 6 months(6 months)
- Barthel Index at 6 months(6 months)
- Life threatening arrhythmias in different hypothermia temperatures(48 hours (during hypothermia))
- Impact on ventricular function of different hypothermia temperatures(48 hours During hypothermia)
研究者
Esteban Lopez de Sa Areses
MD, FESC
Hospital Universitario La Paz