Pulse Pressure and Outcomes After Out-of-Hospital Cardiac Arrest (STEP-PRESS)
STEP-PRESS: Association of Pulse Pressure With Early Mortality and Biomarker Outcomes After Out-of-Hospital Cardiac Arrest
연구 개요
상태
상세 설명
STEP-PRESS is a predefined exploratory observational substudy nested within STEPCARE, an international, multicenter, randomized factorial trial of intensive-care strategies after out-of-hospital cardiac arrest. STEPCARE is registered as NCT05564754. The STEPCARE biomarker substudy is registered as NCT06471972.
STEP-PRESS will use data collected within the STEPCARE trial and applicable substudy approvals. No additional intervention, patient contact, or deviation from STEPCARE clinical management is planned for STEP-PRESS.
The source population will consist of randomized STEPCARE participants, excluding consent withdrawals. Pulse pressure will be calculated as systolic blood pressure minus diastolic blood pressure using recorded STEPCARE blood-pressure values. The primary exposure is cumulative low pulse-pressure burden, defined as the number of hours during 0 to 12 hours after randomization in which interpolated pulse pressure is below 40 mmHg.
The primary analysis population will be restricted to participants alive 12 hours after randomization, without mechanical circulatory support initiated before or within 24 hours after randomization, and with at least three valid recorded blood-pressure observations during 0 to 12 hours after randomization.
The primary outcome is all-cause mortality from the 12-hour landmark to day 7. Key secondary outcomes include mortality in a 24-hour landmark analysis, neurological biomarker endpoints, 30-day mortality, 6-month survival, and 6-month functional outcome. Six-month poor functional outcome will follow the parent STEPCARE definition of modified Rankin Scale score 4 to 6.
All STEP-PRESS objectives are associational. The substudy is not designed to test whether modifying pulse pressure improves outcomes.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Malmö, 스웨덴, 20205
- Department of Intensive Care, Skåne University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Randomized in the STEPCARE trial.
- Out-of-hospital cardiac arrest.
- Stable return of spontaneous circulation, defined in the parent STEPCARE protocol as at least 20 minutes without chest compressions.
- Unconsciousness after sustained return of spontaneous circulation, defined as not being able to obey verbal commands, or intubated and sedated because of agitation.
- Eligible for intensive care without restrictions or limitations.
- Included in STEPCARE within the parent-trial inclusion window.
- For STEP-PRESS analyses, availability of recorded STEPCARE blood-pressure data sufficient to calculate pulse pressure for the relevant analysis population.
- For the primary STEP-PRESS analysis population: alive 12 hours after randomization, without mechanical circulatory support initiated before or within 24 hours after randomization, and with at least three valid recorded blood-pressure observations during 0 to 12 hours after randomization.
Exclusion Criteria:
- Withdrawal of consent for use of STEPCARE trial data.
- Trauma or hemorrhage as the presumed cause of cardiac arrest.
- Suspected or confirmed intracranial hemorrhage.
- On extracorporeal membrane oxygenation before STEPCARE randomization.
- Pregnancy.
- Previously randomized in the STEPCARE trial.
- For STEP-PRESS primary and 24-hour landmark analyses: mechanical circulatory support initiated before or within 24 hours after randomization.
- For endpoint-specific analyses: missing data required to define the relevant exposure, outcome, or biomarker endpoint.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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STEPCARE Participants
Randomized STEPCARE participants included in the STEP-PRESS source population, excluding consent withdrawals.
STEP-PRESS will evaluate pulse-pressure burden as an observational exposure using recorded STEPCARE blood-pressure values.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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All-Cause Mortality From 12 Hours to Day 7
기간: From 12 hours after randomization through day 7 after randomization
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Death from any cause occurring after the 12-hour landmark and through day 7 after randomization, evaluated in relation to cumulative low pulse-pressure burden below 40 mmHg during 0 to 12 hours after randomization.
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From 12 hours after randomization through day 7 after randomization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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All-Cause Mortality in the 24-Hour Landmark Analysis
기간: From 24 hours after randomization through day 7 after randomization
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Death from any cause occurring after the 24-hour landmark and through day 7 after randomization, evaluated in relation to cumulative low pulse-pressure burden below 40 mmHg during 0 to 24 hours after randomization.
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From 24 hours after randomization through day 7 after randomization
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Neurofilament Light Level at 12 Hours
기간: 12 hours after randomization
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Neurofilament light concentration at 12 hours after randomization, analyzed among participants in the STEPCARE biomarker substudy with available biomarker data.
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12 hours after randomization
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Neuron-Specific Enolase Level at 48 Hours
기간: 48 hours after randomization
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Neuron-specific enolase concentration at 48 hours after randomization, analyzed using available STEPCARE measurements.
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48 hours after randomization
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30-Day All-Cause Mortality
기간: 30 days after randomization
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Death from any cause within 30 days after randomization.
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30 days after randomization
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6-Month Survival
기간: 6 months after randomization
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Survival status at 6 months after randomization.
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6 months after randomization
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Poor Functional Outcome at 6 Months
기간: 6 months after randomization
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Poor functional outcome at 6 months after randomization, defined according to the parent STEPCARE definition as modified Rankin Scale score 4 to 6.
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6 months after randomization
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STEP-PRESS
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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