Hypothermia Versus Normothermia After Extracorporeal Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest: A Cluster Randomized Trial (SAVE-J NEUROTHERM Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 468
- 试验地点
- 43
- 主要终点
- Survival
研究概览
简要总结
The SAVE-J NEUROTHERM trial is a cluster randomized trial that evaluated and compared the mortality risk, neurological outcomes, and adverse events between patients who underwent hypothermia and those who underwent normothermia after extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest.
详细描述
Temperature control is a key neurointensive care for post-cardiac arrest patients. Although therapeutic hypothermia has been shown to be effective in the past, recent large randomized controlled trials have failed to demonstrate its efficacy. The international guidelines recommend temperature control under 37.7°C. However, the optimal temperature control, i.e., hypothermia versus normothermia, remains controversial. Additionally, randomized controlled trials that examined temperature control after extracorporeal cardiopulmonary resuscitation (ECPR) are lacking.
ECPR is a resuscitation technique using extracorporeal membrane oxygenation (ECMO) for refractory cardiac arrest. In ECPR patients, ECMO using a heat exchanger can more rapidly achieve the targeted temperature as compared to other temperature control devices. Early cooling to achieve hypothermia after resuscitation is expected to be more effective for neuroprotection in the injured brain. Thus, the investigators hypothesized that hypothermia would be effective in ECPR patients.
Furthermore, ECMO can stabilize the respiratory and circulatory status. Therefore, hypothermia, which may have side effects such as electrolyte abnormalities and arrhythmias, may be safely performed by ECMO. However, ECMO requires the administration of anticoagulants; therefore, it has the risk of hemorrhagic complications. Among patients receiving ECPR, bleeding is a common complication due to its relatively difficult procedure, considering the fact that emergent cannulation is performed under resuscitation. Additionally, CPR-related complications can also result in bleeding. These complications may be enhanced by hypothermia. Therefore, hypothermia after ECPR could contribute to a favorable outcome, but it could also cause bleeding.
The SAVE-J NEUROTHERM trial is a cluster randomized trial that evaluated and compared the mortality risk, neurological outcomes, and adverse events between out-of-hospital cardiac arrest (OHCA) patients who underwent hypothermia and normothermia after ECPR.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-75 years, known or estimated
- •An initial cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia or pulseless electrical activity
排除标准
- •ECMO initiated after sustained return of spontaneous circulation (ROSC) and patients with sustained ROSC before ECMO initiation
- •OHCA of presumed non-cardiac etiology
- •Time from emergency call or witnessed arrest to hospital arrival of >60 min
- •Time from hospital arrival to ECMO initiation of >60 min
- •Pre-hospital ECPR
- •Unavailability of the ECMO heat exchanger for temperature control
- •Glasgow Coma Scale score before temperature control of >8
- •Core body temperature upon hospital arrival of ≤32ºC
- •Surgical intervention before temperature control (e.g., surgical intervention for the primary disease or complications related to resuscitation/ECMO procedures)
- •Do Not Attempt Resuscitation) order confirmed prior to temperature control
- •Limitations in intensive care before temperature control
- •Known cerebral performance category (CPC) of 3-4 before cardiac arrest
- •Known chronic obstructive pulmonary disease with home oxygen therapy
- •Known or suspected pregnancy
- •Concomitant illness, such as malignancy, shortens life expectancy (180-day survival unlikely)
- •Consent not obtained or withdrawn by the participant or surrogate
- •Other reasons, physician's decision not to enroll the patient
研究组 & 干预措施
Normothermia
Temperature control at 36 °C
干预措施: Temperature control (Procedure)
Hypothermia
Temperature control at 33-34 °C
干预措施: Temperature control (Procedure)
结局指标
主要结局
Survival
时间窗: At discharge (approximately 25 days)
次要结局
- Survival(At 30 days, 90 days, and 1 year after admission)
- Neurological function: Cerebral performance categories (CPC)(At discharge (approximately 25 days), 30 days, 90 days, and 1 year after admission)
- Adverse events(During the intensive care unit stay, an average of 2 weeks)
研究者
Akihiko Inoue
Principal Investigator
Kagawa University