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Clinical Trials in Sweden / NCT07586878
Active, not recruiting Observational

Pulse Pressure and Outcomes After Out-of-Hospital Cardiac Arrest

NCT07586878 · tracked via the Priya Life Science Sweden tracker
Sponsor
Region Skane
Phase
Observational
Started
2023-08-17
Last updated
2026-05-22

Condition(s) studied

Out-of-hospital Cardiac Arrest (OHCA)Post-Cardiac Arrest Syndrome

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • All-Cause Mortality From 12 Hours to Day 7 — From 12 hours after randomization through day 7 after randomization
    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.

Trial sites (1)

FacilityCityRegionStatus
Department of Intensive Care, Skåne University Hospital Malmö Sweden

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Other trials for the same condition

Pain After Cardiac Arrest and Resuscitation (PAINCARE) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07586878 on ClinicalTrials.gov ↗ ← All trials in Sweden