Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 600
- 试验地点
- 34
- 主要终点
- Zarit Burden Interview (ZBI)
研究概览
简要总结
To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.
详细描述
This extended follow-up substudy is incorporated into the multi-center, international, factorial randomized Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation -STEPCARE trial (Clinical trials identifier:NCT05564754) were out of hospital cardiac arrest participants will be randomized to different targets of sedation, temperature, and MAP management.
Only selected STEPCARE sites will participate in this extended follow-up substudy. At the extended follow up participating sites all out of hospital cardiac arrest participants randomized in the STEPCARE trial, who survive and provide consent, will be eligible to participate in this substudy, with no further inclusion or exclusion criteria.The extended follow-up substudy is estimated to enroll approximately 600 post OHCA survivors. One nominated caregiver per post OHCA survivor will be invited to be included in the study.
Participants will be followed up at 6 and 12 months.
The primary outcome for this extended follow up substudy is cognitive function at 6 months for the out of hospital cardiac arrest survivors andCaregiver burden at 6 months for the caregivers.
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 (out of hospital cardiac arrest survivors and caregivers) will be blinded. Assessors of neurological prognosis will be blinded. Outcome assessors and investigators will 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
- •All OHCA participants randomized in the STEPCARE trial at the extended follow-up participating sites, who survive and provide consent, with no further inclusion or
排除标准
- •The inclusion and exclusion criteria for the STEPCARE trial are:
- •Inclusion criteria: out-of-hospital cardiac arrest of non-traumatic origin, minimum of 20 minutes without chest compressions (defined as stable return of spontaneous circulation. ROSC), unconsciousness (defined as not being able to obey verbal commands equal to a FOUR-score motor response of <4, or being intubated and sedated because of agitation after sustained ROSC, eligible for intensive care without restrictions or limitation, inclusion within 4 hours (240 minutes) of ROSC (or 220 minutes of stable ROSC).
- •Exclusion criteria: on ECMO prior to randomization, pregnancy, suspected or confirmed intracranial hemorrhage, previously randomized in the STEPCARE trial.
- •For caregivers, the eligibility will be that they live with, or have weekly or more frequent contact (in person or over the telephone) with the post OHCA survivor. Only one nominated caregiver per post OHCA survivor will be able to be included in the study. This would typically be the caregiver that would identify as the primary caregiver of the post OHCA survivor if needed, but may also be another close family member.
研究组 & 干预措施
Minimal sedation, no temperature device and high MAP
干预措施: High MAP (Other)
Minimal sedation, no temperature device and high MAP
干预措施: Fever control without a device (Other)
Minimal sedation, no temperature device and high MAP
干预措施: Minimal sedation (Other)
Minimal sedation, temperature device and low MAP
干预措施: Feed back controlled temperature device (Device)
Minimal sedation, temperature device and low MAP
干预措施: Low MAP (Other)
Minimal sedation, temperature device and low MAP
干预措施: Minimal sedation (Other)
Minimal sedation, no temperature device and low MAP
干预措施: Fever control without a device (Other)
Minimal sedation, no temperature device and low MAP
干预措施: Low MAP (Other)
Minimal sedation, no temperature device and low MAP
干预措施: Minimal sedation (Other)
Sedation, temperature device and high MAP
干预措施: Feed back controlled temperature device (Device)
Sedation, temperature device and high MAP
干预措施: High MAP (Other)
Minimal sedation, temperature device, and high MAP
干预措施: Minimal sedation (Other)
Sedation, temperature device and high MAP
干预措施: Deep sedation (Other)
Sedation, no temperature device and high MAP
干预措施: High MAP (Other)
Sedation, no temperature device and high MAP
干预措施: Deep sedation (Other)
Sedation, no temperature device and high MAP
干预措施: Fever control without a device (Other)
Sedation, temperature device and low MAP
干预措施: Feed back controlled temperature device (Device)
Sedation, temperature device and low MAP
干预措施: Deep sedation (Other)
Sedation, temperature device and low MAP
干预措施: Low MAP (Other)
Sedation, no temperature device, and low MAP
干预措施: Deep sedation (Other)
Sedation, no temperature device, and low MAP
干预措施: Fever control without a device (Other)
Sedation, no temperature device, and low MAP
干预措施: Low MAP (Other)
Minimal sedation, temperature device, and high MAP
干预措施: Feed back controlled temperature device (Device)
Minimal sedation, temperature device, and high MAP
干预措施: High MAP (Other)
结局指标
主要结局
Zarit Burden Interview (ZBI)
时间窗: 6 months
Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden
Montreal Cognitive Assessment (MoCA)
时间窗: 6 months
Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition
次要结局
未报告次要终点