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Pulse Pressure and Outcomes After Out-of-Hospital Cardiac Arrest (STEP-PRESS)

18. mai 2026 oppdatert av: Region Skane

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

3500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sverige
      • Malmö, Sverige, 20205
        • Department of Intensive Care, Skåne University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-Cause Mortality From 12 Hours to Day 7
Tidsramme: 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.
From 12 hours after randomization through day 7 after randomization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-Cause Mortality in the 24-Hour Landmark Analysis
Tidsramme: From 24 hours after randomization through day 7 after randomization
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.
From 24 hours after randomization through day 7 after randomization
Neurofilament Light Level at 12 Hours
Tidsramme: 12 hours after randomization
Neurofilament light concentration at 12 hours after randomization, analyzed among participants in the STEPCARE biomarker substudy with available biomarker data.
12 hours after randomization
Neuron-Specific Enolase Level at 48 Hours
Tidsramme: 48 hours after randomization
Neuron-specific enolase concentration at 48 hours after randomization, analyzed using available STEPCARE measurements.
48 hours after randomization
30-Day All-Cause Mortality
Tidsramme: 30 days after randomization
Death from any cause within 30 days after randomization.
30 days after randomization
6-Month Survival
Tidsramme: 6 months after randomization
Survival status at 6 months after randomization.
6 months after randomization
Poor Functional Outcome at 6 Months
Tidsramme: 6 months after randomization
Poor functional outcome at 6 months after randomization, defined according to the parent STEPCARE definition as modified Rankin Scale score 4 to 6.
6 months after randomization

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Region Skane

Publikasjoner og nyttige lenker

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Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. august 2023

Primær fullføring (Antatt)

19. mai 2026

Studiet fullført (Antatt)

1. oktober 2028

Datoer for studieregistrering

Først innsendt

8. mai 2026

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STEP-PRESS

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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