Pulse Pressure and Outcomes After Out-of-Hospital Cardiac Arrest (NCT07586878) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pulse Pressure and Outcomes After Out-of-Hospital Cardiac Arrest
Sweden3,500 participantsStarted 2023-08-17
Plain-language summary
STEP-PRESS is a predefined exploratory observational substudy nested within the STEPCARE trial. The study will evaluate whether early low pulse-pressure burden after out-of-hospital cardiac arrest is associated with early mortality and selected biomarker outcomes. Pulse pressure will be calculated as systolic blood pressure minus diastolic blood pressure using recorded STEPCARE blood-pressure values. The primary exposure is cumulative hours with pulse pressure below 40 mmHg during the first 12 hours after randomization. The primary outcome is all-cause mortality from the 12-hour landmark to day 7.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is observational and focuses on pulse pressure as a way to predict outcomes after out-of-hospital cardiac arrest — does my own pulse pressure data from my resuscitation tell you anything useful about my prognosis right now?
2Since the trial is no longer recruiting but is still active, does that mean results might be available soon, and could those findings change how you manage my post-cardiac arrest care?
3The study is measuring all-cause mortality from 12 hours to day 7 after cardiac arrest — based on where I am in that window, how are you currently using hemodynamic signals like pulse pressure to guide my treatment decisions?
4Post-cardiac arrest syndrome involves a lot of different complications — are there specific aspects of my cardiovascular stability that you're already monitoring that overlap with what this trial is studying, and what does that tell you about my situation?
5If this research eventually shows that pulse pressure is a reliable early warning signal after cardiac arrest, how might that change the standard approach to monitoring and treating patients like me in the ICU?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All-Cause Mortality From 12 Hours to Day 7
Timeframe: From 12 hours after randomization through day 7 after randomization