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

18 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

3500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Suède
- - Malmö, Suède, 20205
    - Department of Intensive Care, Skåne University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
All-Cause Mortality From 12 Hours to Day 7 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
All-Cause Mortality in the 24-Hour Landmark Analysis Délai: 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 Délai: 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 Délai: 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 Délai: 30 days after randomization	Death from any cause within 30 days after randomization.	30 days after randomization
6-Month Survival Délai: 6 months after randomization	Survival status at 6 months after randomization.	6 months after randomization
Poor Functional Outcome at 6 Months Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Region Skane

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

STEPCARE Trial Website

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 août 2023

Achèvement primaire (Estimé)

19 mai 2026

Achèvement de l'étude (Estimé)

1 octobre 2028

Dates d'inscription aux études

Première soumission

8 mai 2026

Première soumission répondant aux critères de contrôle qualité

8 mai 2026

Première publication (Réel)

14 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

STEP-PRESS

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .