Out-of-hospital Cardiac Arrest (OHCA)STEP-PRESSNCT07586878
Pulse Pressure and Outcomes After Out-of-Hospital Cardiac Arrest
An observational study of Out-of-hospital Cardiac Arrest (OHCA) and Post-Cardiac Arrest Syndrome, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest (OHCA), Post-Cardiac Arrest Syndrome
- How many people
- 3,500 participants
- Where
- 1 siteSweden
- Study dates
- 17 Aug 2023to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Intensive Care, Skåne University Hospital
Malmö, 20205
About this study
Official title: STEP-PRESS: Association of Pulse Pressure With Early Mortality and Biomarker Outcomes After Out-of-Hospital Cardiac Arrest
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.
Read the detailed description
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.
- Keywords
- Pulse Pressure, Blood Pressure, Hemodynamics, Mortality, Biomarkers, Neurofilament Light, Neuron-Specific Enolase
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 12 hours after randomization through day 7 after randomization
Secondary outcomes (6)
All-Cause Mortality in the 24-Hour Landmark Analysis
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.
Measured: From 24 hours after randomization through day 7 after randomization
Neurofilament Light Level at 12 Hours
Neurofilament light concentration at 12 hours after randomization, analyzed among participants in the STEPCARE biomarker substudy with available biomarker data.
Measured: 12 hours after randomization
Neuron-Specific Enolase Level at 48 Hours
Neuron-specific enolase concentration at 48 hours after randomization, analyzed using available STEPCARE measurements.
Measured: 48 hours after randomization
30-Day All-Cause Mortality
Death from any cause within 30 days after randomization.
Measured: 30 days after randomization
6-Month Survival
Survival status at 6 months after randomization.
Measured: 6 months after randomization
Poor Functional Outcome at 6 Months
Poor functional outcome at 6 months after randomization, defined according to the parent STEPCARE definition as modified Rankin Scale score 4 to 6.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start17 Aug 2023
- Primary completion19 May 2026 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-hospital Cardiac Arrest (OHCA)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586878
- Sponsor's protocol ID
- STEP-PRESS
- Acronym
- STEP-PRESS
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: STEP-PRESS will use deidentified or pseudonymized data from the parent STEPCARE trial according to STEPCARE governance procedures. Individual participant data sharing is determined by the STEPCARE sponsor and trial governance, not by the STEP-PRESS substudy investigators alone. Therefore, the IPD sharing plan for this substudy is currently undecided.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEP-PRESS: Association of Pulse Pressure With Early Mortality and Biomarker Outcomes After Out-of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT07586878
- Acronym / sponsor ID
- STEP-PRESS / STEP-PRESS
- Keywords
- Pulse Pressure, Blood Pressure, Hemodynamics, Mortality, Biomarkers, Neurofilament Light, Neuron-Specific Enolase
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 19 May 2026 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-Cause Mortality From 12 Hours to Day 7
Time frame: 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.
6 secondary outcomes
All-Cause Mortality in the 24-Hour Landmark Analysis
Time frame: From 24 hours after randomization through day 7 after randomization
Neurofilament Light Level at 12 Hours
Time frame: 12 hours after randomization
Neuron-Specific Enolase Level at 48 Hours
Time frame: 48 hours after randomization
30-Day All-Cause Mortality
Time frame: 30 days after randomization
6-Month Survival
Time frame: 6 months after randomization
Poor Functional Outcome at 6 Months
Time frame: 6 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- STEPCARE Trial WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. STEP-PRESS will use deidentified or pseudonymized data from the parent STEPCARE trial according to STEPCARE governance procedures. Individual participant data sharing is determined by the STEPCARE sponsor and trial governance, not by the STEP-PRESS substudy investigators alone. Therefore, the IPD sharing plan for this substudy is currently undecided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-of-hospital Cardiac Arrest (OHCA) and Post-Cardiac Arrest Syndrome, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality From 12 Hours to Day 7 (time frame: From 12 hours after randomization through day 7 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.