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临床试验/NCT06207942
NCT06207942招募中不适用

Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial

Region Skane37 个研究点 分布在 10 个国家目标入组 600 人开始时间: 2023年8月1日最近更新:
适应症

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
37
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

入选标准

  • 未提供

排除标准

  • 未提供

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

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (37)

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