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

18 maj 2026 uppdaterad 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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

3500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
All-Cause Mortality From 12 Hours to Day 7
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
All-Cause Mortality in the 24-Hour Landmark Analysis
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 30 days after randomization
Death from any cause within 30 days after randomization.
30 days after randomization
6-Month Survival
Tidsram: 6 months after randomization
Survival status at 6 months after randomization.
6 months after randomization
Poor Functional Outcome at 6 Months
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Region Skane

Publikationer och användbara länkar

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Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 augusti 2023

Primärt slutförande (Beräknad)

19 maj 2026

Avslutad studie (Beräknad)

1 oktober 2028

Studieregistreringsdatum

Först inskickad

8 maj 2026

Först inskickad som uppfyllde QC-kriterierna

8 maj 2026

Första postat (Faktisk)

14 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STEP-PRESS

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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