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Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE) (STEPCARE-MAKE)

2026年5月29日 更新者：Miikka Keski-Keturi、Helsinki University Central Hospital

Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE): a Protocol for a Pre-planned Sub-study of a Randomized Clinical Trial

The STEPCARE-MAKE study is a predefined sub-study of the large Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial, which evaluates the effects of three interventions in comatose adult patients resuscitated from out-of-hospital cardiac arrest. In this sub-study, all 3500 participants enrolled in the main trial are assessed for major adverse kidney events (MAKE) and creatinine kinetics.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

The main STEPCARE trial randomizes patients to three different interventions: (1) continuous deep sedation for 36 hours or minimal sedation (with extubation if feasible), (2) fever control with or without a feedback-controlled device if the temperature rises above 37.7°C, and (3) a mean arterial pressure (MAP) target of ≥65 mmHg or ≥85 mmHg.

This sub-study evaluates the effects of these three interventions on major adverse kidney events (MAKE), defined as a composite of death within 30 days, initiation of renal replacement therapy during the stay in the primary hospital, or persistent renal dysfunction, defined as a final creatinine value ≥200% of baseline at the time of discharge from the primary hospital.

Creatinine kinetics during the stay in the primary hospital and within 72 hours post-resuscitation are evaluated as secondary outcomes.

All data are collected prospectively as part of the main trial protocol, and analyses will be conducted according to a predefined statistical analysis plan.

研究类型

介入性

注册 (估计的)

3500

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 卢森堡
      • Luxembourg、卢森堡
        • Centre Hospitalier de Luxembourg
  • 德国
      • Berlin、德国
        • Charite University Hospital
      • Lübeck、德国
        • Lübeck University Hospital
      • Tübingen、德国
        • Tubingen University Hospital
  • 意大利
      • Genova、意大利
        • San Martino Hospital Genova
  • 挪威
      • Arendal、挪威
        • Soerlandet Hospital Arendal
      • Grålum、挪威
        • Kalnes Hospital
      • Oslo、挪威
        • Oslo University Hospital
      • Stavanger、挪威
        • Stavanger University Hospital
  • 新加坡
      • Singapore、新加坡
        • Tan Tock Seng Hospital
  • 新西兰
      • Auckland、新西兰
        • DCCM ICU
      • Auckland、新西兰
        • Middlemore ICU
      • Auckland、新西兰
        • North Shore ICU NZ
      • Christchurch、新西兰
        • Christchurch Hospital
      • Wellington、新西兰
        • Wellington Hospital
  • 比利时
      • Brussels、比利时
        • HUB Hôpital Erasme
      • Ghent、比利时
        • Ghent University Hospital
      • Lanaken、比利时
        • Ziekenhuis Oost-Limburg Hospital
  • 沙特阿拉伯
      • Riyadh、沙特阿拉伯
        • King Abdulaziz Medical City
  • 澳大利亚
      • Brisbane、澳大利亚
        • Princess Alexandra Hospital
      • Brisbane、澳大利亚
        • The Prince Charles Hospital
      • Kingswood、澳大利亚
        • Nepean Hospital
      • Liverpool、澳大利亚
        • Liverpool Hospital
      • Melbourne、澳大利亚
        • Austin Hospital
      • Sydney、澳大利亚
        • Royal North Shore Hospital
      • Sydney、澳大利亚
        • St George Hospital
      • Sydney、澳大利亚
        • The Sutherland Hospital
  • 爱沙尼亚
      • Tallinn、爱沙尼亚
        • North Estonia Medical Centre
  • 瑞典
      • Gothenburg、瑞典
        • Sahlgrenska University Hospital
      • Halmstad、瑞典
        • Hallands hospital
      • Helsingborg、瑞典
        • Helsingborg Hospital
      • Karlstad、瑞典
        • Karlstad Hospital
      • Lund、瑞典
        • Skane University Hospital
      • Malmö、瑞典
        • Skåne University Hospital Malmö
      • Skövde、瑞典
        • Skaraborg Hospital Skovde
      • Stockholm、瑞典
        • Karolinska University Hospital
      • Umeå、瑞典
        • University Hospital of Umeå
  • 瑞士
      • Bern、瑞士
        • Bern University Hospital
      • Sankt Gallen、瑞士
        • St Gallen Hospital
      • Zurich、瑞士
        • University Hospital Zurich
  • 芬兰
      • Espoo、芬兰
        • Jorvi Hospital
      • Helsinki、芬兰、00290
        • Meilahti Hospital
      • Jyväskylä、芬兰
        • Jyväskylä Hospital
      • Kuopio、芬兰
        • Kuopio University Hospital
      • Oulu、芬兰
        • Oulu University Hospital
  • 英国
      • Basildon、英国
        • Essex cardiothoracic centre
      • Bristol、英国
        • Bristol Royal Infirmary
      • Cardiff、英国
        • Cardiff University Hospital
      • Leeds、英国
        • Leeds General Infirmary
      • London、英国
        • St Bartholomew's Hospital
      • London、英国
        • St Georges University Hospital
      • London、英国
        • Kings College Hospita

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • All patients included to the main STEPCARE-trial are also included to this substudy
  • Out-of-hospital cardiac arrest
  • Sustained return of spontaneous circulation, defined as 20 minutes with signs of circulation without the need for chest compressions
  • Unconsciousness (FOUR-score motor response <4, inability to obey verbal commands), or being intubated and sedated due to agitation
  • Eligible for intensive care without restrictions or limitations
  • Inclusion within 4 hours of the return of spontaneous circulation

Exclusion Criteria:

  • Out-of-hospital cardiac arrest of presumed traumatic or hemorrhagic origin
  • Confirmed or suspected intracranial hemorrhage
  • Pregnancy
  • Extracorporeal membrane oxygenation (ECMO) prior to randomization
  • No additional exclusion criteria are applied beyond those of the main STEPCARE trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Sedation, temperature device and high MAP
Continuous deep sedation for 36 hours, fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥85mmHg
其他：深度镇静
深度镇静至少36小时
设备：Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
其他：High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
有源比较器：Sedation, no temperature device and high MAP
Continuous deep sedation for 36 hours, fever management without a feedback-controlled device and a mean arterial pressure target of ≥85mmHg
其他：深度镇静
深度镇静至少36小时
其他：没有设备的发烧控制
在没有设备的情况下管理 ICU 中的发烧
其他：High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
有源比较器：Sedation, temperature device and low MAP
Continuous deep sedation for 36 hours, fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥65mmHg
其他：深度镇静
深度镇静至少36小时
设备：Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
其他：Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
有源比较器：Sedation, no temperature device and low MAP
Continuous deep sedation for 36 hours, fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
其他：深度镇静
深度镇静至少36小时
其他：没有设备的发烧控制
在没有设备的情况下管理 ICU 中的发烧
其他：Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
有源比较器：Minimal sedation, temperature device and high MAP
Minimal sedation (and early extubation if possible), fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥85mmHg
设备：Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
其他：High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
其他：Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
有源比较器：Minimal sedation, no temperature device and high MAP
Minimal sedation (and early extubation if possible), fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
其他：没有设备的发烧控制
在没有设备的情况下管理 ICU 中的发烧
其他：High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
其他：Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
有源比较器：Minimal sedation, temperature device and low MAP
Minimal sedation (and early extubation if possible), fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥65mmHg
设备：Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
其他：Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
其他：Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
有源比较器：Minimal sedation, no temperature device and low MAP
Minimal sedation (and early extubation if possible), fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
其他：没有设备的发烧控制
在没有设备的情况下管理 ICU 中的发烧
其他：Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
其他：Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Major adverse kidney event (MAKE)
大体时间：30 days
A composite endpoint of MAKE: death from any cause by day 30, initiation of RRT during the stay in the primary hospital or persistent renal dysfunction defined as final creatinine value ≥200 % of the baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) at the time of discharge from the primary hospital
30 days

次要结果测量

结果测量
措施说明
大体时间
Difference between baseline and the highest in-hospital creatinine
大体时间：During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest in-hospital creatinine
During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
Difference between baseline and the last measured in-hospital creatinine
大体时间：At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the last measured in-hospital creatinine (in the primary hospital)
At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
Difference between baseline and 72-hour creatinine
大体时间：72 hours
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and 72-hour creatinine
72 hours
Difference between baseline and the highest creatinine within 72 hours
大体时间：72 hours
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest creatinine within 72 hours
72 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Helsinki University Central Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年8月17日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年6月2日

上次提交的符合 QC 标准的更新

2026年5月29日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • STEPCARE-MAKE

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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