Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 入组人数
- 3,500
- 试验地点
- 108
- 主要终点
- Mortality
研究概览
简要总结
The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.
详细描述
3500 patients who are comatose after cardiac arrest will be included in a trial studying three separate targets. All patients will be randomised to a control or an intervention arm for sedation, temperature and blood pressure targets. These are.
- Continuous deep sedation for 36 hours or minimal sedation (SEDCARE)
- Fever management with or without a feedback-controlled device (TEMPCARE)
- A mean arterial pressure target of >85mmHg or >65mmHg. (MAPCARE)
Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be blinded. Assessors of neurological prognosis will be blinded. Outcome assessors and investigators will be blinded. Health-care personnel will not be blinded.
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
- •Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
- •Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of <4) or being intubated and sedated because of agitation after sustained ROSC.
- •Eligible for intensive care without restrictions or limitations
- •Inclusion within 4 hours of ROSC
排除标准
- •On ECMO prior to randomization
- •Suspected or confirmed intracranial hemorrhage
- •Previously randomized in the STEPCARE trial
- •Trauma or hemorrhage being the presumed cause of arrest
研究组 & 干预措施
Minimal sedation, temperature device and low MAP
Minimal sedation (and early extubation if possible). Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >65mmHg.
干预措施: Minimal sedation (Other)
Minimal sedation, no temperature device and low MAP
Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
干预措施: Fever control without a device (Other)
Sedation, temperature device and high MAP
Continuous deep sedation for 36 hours Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >85mmHg.
干预措施: Feedback-controlled temperature device (Device)
Sedation, temperature device and high MAP
Continuous deep sedation for 36 hours Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >85mmHg.
干预措施: High MAP (Other)
Sedation, temperature device and high MAP
Continuous deep sedation for 36 hours Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >85mmHg.
干预措施: Deep sedation (Other)
Sedation, no temperature device and high MAP
Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >85mmHg.
干预措施: High MAP (Other)
Sedation, no temperature device and high MAP
Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >85mmHg.
干预措施: Deep sedation (Other)
Sedation, no temperature device and low MAP
Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
干预措施: Deep sedation (Other)
Sedation, no temperature device and low MAP
Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
干预措施: Fever control without a device (Other)
Sedation, no temperature device and low MAP
Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
干预措施: Low MAP (Other)
Minimal sedation, temperature device and high MAP
Minimal sedation (and early extubation if possible). Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >85mmHg.
干预措施: Feedback-controlled temperature device (Device)
Minimal sedation, temperature device and high MAP
Minimal sedation (and early extubation if possible). Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >85mmHg.
干预措施: High MAP (Other)
Minimal sedation, temperature device and high MAP
Minimal sedation (and early extubation if possible). Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >85mmHg.
干预措施: Minimal sedation (Other)
Minimal sedation, no temperature device and high MAP
Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
干预措施: High MAP (Other)
Minimal sedation, no temperature device and high MAP
Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
干预措施: Fever control without a device (Other)
Sedation, temperature device and low MAP
Continuous deep sedation for 36 hours. Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >65mmHg.
干预措施: Low MAP (Other)
Sedation, no temperature device and high MAP
Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >85mmHg.
干预措施: Fever control without a device (Other)
Sedation, temperature device and low MAP
Continuous deep sedation for 36 hours. Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >65mmHg.
干预措施: Feedback-controlled temperature device (Device)
Sedation, temperature device and low MAP
Continuous deep sedation for 36 hours. Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >65mmHg.
干预措施: Deep sedation (Other)
Minimal sedation, no temperature device and high MAP
Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
干预措施: Minimal sedation (Other)
Minimal sedation, temperature device and low MAP
Minimal sedation (and early extubation if possible). Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >65mmHg.
干预措施: Feedback-controlled temperature device (Device)
Minimal sedation, temperature device and low MAP
Minimal sedation (and early extubation if possible). Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >65mmHg.
干预措施: Low MAP (Other)
Minimal sedation, no temperature device and low MAP
Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
干预措施: Low MAP (Other)
Minimal sedation, no temperature device and low MAP
Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg.
干预措施: Minimal sedation (Other)
结局指标
主要结局
Mortality
时间窗: 6 months
Landmark mortality at follow-up performed at 6 months
次要结局
- Health-related quality of life(6 months)
- Functional outcome(6 months)