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

NCT07586878 | Active Not Recruiting

• 1 other identifier: STEP-PRESS
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pulse Pressure; Blood Pressure; Hemodynamics; Mortality; Biomarkers; Neurofilament Light; Neuron-Specific Enolase

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality From 12 Hours to Day 7

  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.

  From 12 hours after randomization through day 7 after randomization

Secondary Outcomes (6)

• All-Cause Mortality in the 24-Hour Landmark Analysis

  From 24 hours after randomization through day 7 after randomization

• Neurofilament Light Level at 12 Hours

  12 hours after randomization

• Neuron-Specific Enolase Level at 48 Hours

  48 hours after randomization

• 30-Day All-Cause Mortality

  30 days after randomization

• 6-Month Survival

  6 months after randomization

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Randomized STEPCARE participants with available trial data for STEP-PRESS analyses. The STEP-PRESS source population consists of randomized STEPCARE participants excluding consent withdrawals. The primary analysis population is restricted to participants alive 12 hours after randomization, without mechanical circulatory support initiated before or within 24 hours after randomization, and with sufficient valid blood-pressure observations during 0 to 12 hours after randomization.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Intensive Care, Skåne University Hospital

Malmö, 20205, Sweden

Location

Related Links

• STEPCARE Trial Website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples collected in the STEPCARE biomarker substudy

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Post-Cardiac Arrest Syndrome; Charcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: August 17, 2023
• Primary Completion: May 19, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

SE (1)