Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE) (STEPCARE-MAKE)
2026년 5월 29일 업데이트: 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.
연구 개요
상태
모집하지 않고 적극적으로
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
3500
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arendal, 노르웨이
- Soerlandet Hospital Arendal
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Grålum, 노르웨이
- Kalnes Hospital
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Oslo, 노르웨이
- Oslo University Hospital
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Stavanger, 노르웨이
- Stavanger University Hospital
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Auckland, 뉴질랜드
- DCCM ICU
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Auckland, 뉴질랜드
- Middlemore ICU
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Auckland, 뉴질랜드
- North Shore ICU NZ
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Christchurch, 뉴질랜드
- Christchurch Hospital
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Wellington, 뉴질랜드
- Wellington Hospital
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Berlin, 독일
- Charite University Hospital
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Lübeck, 독일
- Lübeck University Hospital
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Tübingen, 독일
- Tubingen University Hospital
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Luxembourg, 룩셈부르크
- Centre Hospitalier de Luxembourg
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Brussels, 벨기에
- HUB Hôpital Erasme
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Ghent, 벨기에
- Ghent University Hospital
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Lanaken, 벨기에
- Ziekenhuis Oost-Limburg Hospital
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Riyadh, 사우디 아라비아
- King Abdulaziz Medical City
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Gothenburg, 스웨덴
- Sahlgrenska University Hospital
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Halmstad, 스웨덴
- Hallands hospital
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Helsingborg, 스웨덴
- Helsingborg Hospital
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Karlstad, 스웨덴
- Karlstad Hospital
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Lund, 스웨덴
- Skane University Hospital
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Malmö, 스웨덴
- Skåne University Hospital Malmö
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Skövde, 스웨덴
- Skaraborg Hospital Skovde
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Stockholm, 스웨덴
- Karolinska University Hospital
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Umeå, 스웨덴
- University Hospital of Umeå
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Bern, 스위스
- Bern University Hospital
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Sankt Gallen, 스위스
- St Gallen Hospital
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Zurich, 스위스
- University Hospital Zurich
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Singapore, 싱가포르
- Tan Tock Seng Hospital
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Tallinn, 에스토니아
- North Estonia Medical Centre
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Basildon, 영국
- Essex cardiothoracic centre
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Bristol, 영국
- Bristol Royal Infirmary
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Cardiff, 영국
- Cardiff University Hospital
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Leeds, 영국
- Leeds General Infirmary
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London, 영국
- St Bartholomew's Hospital
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London, 영국
- St Georges University Hospital
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London, 영국
- Kings College Hospita
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Genova, 이탈리아
- San Martino Hospital Genova
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Espoo, 핀란드
- Jorvi Hospital
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Helsinki, 핀란드, 00290
- Meilahti Hospital
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Jyväskylä, 핀란드
- Jyväskylä Hospital
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Kuopio, 핀란드
- Kuopio University Hospital
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Oulu, 핀란드
- Oulu University Hospital
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Brisbane, 호주
- Princess Alexandra Hospital
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Brisbane, 호주
- The Prince Charles Hospital
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Kingswood, 호주
- Nepean Hospital
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Liverpool, 호주
- Liverpool Hospital
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Melbourne, 호주
- Austin Hospital
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Sydney, 호주
- Royal North Shore Hospital
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Sydney, 호주
- St George Hospital
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Sydney, 호주
- The Sutherland Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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
|
최소 36시간 동안 깊은 진정
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
A MAP target of >85mmHg will be used.
Vasopressors will be titrated to this target during 36h
|
|
활성 비교기: 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
|
최소 36시간 동안 깊은 진정
장비 없이 중환자실에서 발열 관리
A MAP target of >85mmHg will be used.
Vasopressors will be titrated to this target during 36h
|
|
활성 비교기: 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
|
최소 36시간 동안 깊은 진정
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
A MAP target of >65mmHg will be used.
Vasopressors will be titrated to this target during 36h
|
|
활성 비교기: 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
|
최소 36시간 동안 깊은 진정
장비 없이 중환자실에서 발열 관리
A MAP target of >65mmHg will be used.
Vasopressors will be titrated to this target during 36h
|
|
활성 비교기: 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
|
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
A MAP target of >85mmHg will be used.
Vasopressors will be titrated to this target during 36h
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
|
|
활성 비교기: 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
|
장비 없이 중환자실에서 발열 관리
A MAP target of >85mmHg will be used.
Vasopressors will be titrated to this target during 36h
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
|
|
활성 비교기: 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
|
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
A MAP target of >65mmHg will be used.
Vasopressors will be titrated to this target during 36h
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
|
|
활성 비교기: 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
|
장비 없이 중환자실에서 발열 관리
A MAP target of >65mmHg will be used.
Vasopressors will be titrated to this target during 36h
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Major adverse kidney event (MAKE)
기간: 30 days
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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
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30 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference between baseline and the highest in-hospital creatinine
기간: During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
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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
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During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
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Difference between baseline and the last measured in-hospital creatinine
기간: At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
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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)
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At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
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Difference between baseline and 72-hour creatinine
기간: 72 hours
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Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and 72-hour creatinine
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72 hours
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Difference between baseline and the highest creatinine within 72 hours
기간: 72 hours
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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
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72 hours
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 8월 17일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2026년 12월 1일
연구 등록 날짜
최초 제출
2026년 4월 28일
QC 기준을 충족하는 최초 제출
2026년 5월 6일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 29일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STEPCARE-MAKE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .