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Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE) (STEPCARE-MAKE)

29 mai 2026 mis à jour par: Miikka Keski-Keturi, Helsinki University Central Hospital

Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE): a Protocol for a Pre-planned Sub-study of a Randomized Clinical Trial

The STEPCARE-MAKE study is a predefined sub-study of the large Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial, which evaluates the effects of three interventions in comatose adult patients resuscitated from out-of-hospital cardiac arrest. In this sub-study, all 3500 participants enrolled in the main trial are assessed for major adverse kidney events (MAKE) and creatinine kinetics.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

The main STEPCARE trial randomizes patients to three different interventions: (1) continuous deep sedation for 36 hours or minimal sedation (with extubation if feasible), (2) fever control with or without a feedback-controlled device if the temperature rises above 37.7°C, and (3) a mean arterial pressure (MAP) target of ≥65 mmHg or ≥85 mmHg.

This sub-study evaluates the effects of these three interventions on major adverse kidney events (MAKE), defined as a composite of death within 30 days, initiation of renal replacement therapy during the stay in the primary hospital, or persistent renal dysfunction, defined as a final creatinine value ≥200% of baseline at the time of discharge from the primary hospital.

Creatinine kinetics during the stay in the primary hospital and within 72 hours post-resuscitation are evaluated as secondary outcomes.

All data are collected prospectively as part of the main trial protocol, and analyses will be conducted according to a predefined statistical analysis plan.

Type d'étude

Interventionnel

Inscription (Estimé)

3500

Phase

  • N'est pas applicable

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

  • Allemagne
      • Berlin, Allemagne
        • Charite University Hospital
      • Lübeck, Allemagne
        • Lübeck University Hospital
      • Tübingen, Allemagne
        • Tubingen University Hospital
  • Arabie Saoudite
      • Riyadh, Arabie Saoudite
        • King Abdulaziz Medical City
  • Australie
      • Brisbane, Australie
        • Princess Alexandra Hospital
      • Brisbane, Australie
        • The Prince Charles Hospital
      • Kingswood, Australie
        • Nepean Hospital
      • Liverpool, Australie
        • Liverpool Hospital
      • Melbourne, Australie
        • Austin Hospital
      • Sydney, Australie
        • Royal North Shore Hospital
      • Sydney, Australie
        • St George Hospital
      • Sydney, Australie
        • The Sutherland Hospital
  • Belgique
      • Brussels, Belgique
        • HUB Hôpital Erasme
      • Ghent, Belgique
        • Ghent University Hospital
      • Lanaken, Belgique
        • Ziekenhuis Oost-Limburg Hospital
  • Estonie
      • Tallinn, Estonie
        • North Estonia Medical Centre
  • Finlande
      • Espoo, Finlande
        • Jorvi Hospital
      • Helsinki, Finlande, 00290
        • Meilahti Hospital
      • Jyväskylä, Finlande
        • Jyväskylä Hospital
      • Kuopio, Finlande
        • Kuopio University Hospital
      • Oulu, Finlande
        • Oulu University Hospital
  • Italie
      • Genova, Italie
        • San Martino Hospital Genova
  • Luxembourg
      • Luxembourg, Luxembourg
        • Centre Hospitalier de Luxembourg
  • Norvège
      • Arendal, Norvège
        • Soerlandet Hospital Arendal
      • Grålum, Norvège
        • Kalnes Hospital
      • Oslo, Norvège
        • Oslo University Hospital
      • Stavanger, Norvège
        • Stavanger University Hospital
  • Nouvelle-Zélande
      • Auckland, Nouvelle-Zélande
        • DCCM ICU
      • Auckland, Nouvelle-Zélande
        • Middlemore ICU
      • Auckland, Nouvelle-Zélande
        • North Shore ICU NZ
      • Christchurch, Nouvelle-Zélande
        • Christchurch Hospital
      • Wellington, Nouvelle-Zélande
        • Wellington Hospital
  • Royaume-Uni
      • Basildon, Royaume-Uni
        • Essex cardiothoracic centre
      • Bristol, Royaume-Uni
        • Bristol Royal Infirmary
      • Cardiff, Royaume-Uni
        • Cardiff University Hospital
      • Leeds, Royaume-Uni
        • Leeds General Infirmary
      • London, Royaume-Uni
        • St Bartholomew's Hospital
      • London, Royaume-Uni
        • St Georges University Hospital
      • London, Royaume-Uni
        • Kings College Hospita
  • Singapour
      • Singapore, Singapour
        • Tan Tock Seng Hospital
  • Suisse
      • Bern, Suisse
        • Bern University Hospital
      • Sankt Gallen, Suisse
        • St Gallen Hospital
      • Zurich, Suisse
        • University Hospital Zurich
  • Suède
      • Gothenburg, Suède
        • Sahlgrenska University Hospital
      • Halmstad, Suède
        • Hallands hospital
      • Helsingborg, Suède
        • Helsingborg Hospital
      • Karlstad, Suède
        • Karlstad Hospital
      • Lund, Suède
        • Skane University Hospital
      • Malmö, Suède
        • Skåne University Hospital Malmö
      • Skövde, Suède
        • Skaraborg Hospital Skovde
      • Stockholm, Suède
        • Karolinska University Hospital
      • Umeå, Suède
        • University Hospital of Umeå

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

La description

Inclusion Criteria:

  • All patients included to the main STEPCARE-trial are also included to this substudy
  • Out-of-hospital cardiac arrest
  • Sustained return of spontaneous circulation, defined as 20 minutes with signs of circulation without the need for chest compressions
  • Unconsciousness (FOUR-score motor response <4, inability to obey verbal commands), or being intubated and sedated due to agitation
  • Eligible for intensive care without restrictions or limitations
  • Inclusion within 4 hours of the return of spontaneous circulation

Exclusion Criteria:

  • Out-of-hospital cardiac arrest of presumed traumatic or hemorrhagic origin
  • Confirmed or suspected intracranial hemorrhage
  • Pregnancy
  • Extracorporeal membrane oxygenation (ECMO) prior to randomization
  • No additional exclusion criteria are applied beyond those of the main STEPCARE trial

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

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Sedation, temperature device and high MAP
Continuous deep sedation for 36 hours, fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥85mmHg
Autre: Sédation profonde
Sédation profonde pendant au moins 36h
Dispositif: Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
Autre: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Comparateur actif: Sedation, no temperature device and high MAP
Continuous deep sedation for 36 hours, fever management without a feedback-controlled device and a mean arterial pressure target of ≥85mmHg
Autre: Sédation profonde
Sédation profonde pendant au moins 36h
Autre: Contrôle de la fièvre sans appareil
Prise en charge de la fièvre en réanimation sans appareil
Autre: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Comparateur actif: Sedation, temperature device and low MAP
Continuous deep sedation for 36 hours, fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥65mmHg
Autre: Sédation profonde
Sédation profonde pendant au moins 36h
Dispositif: Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
Autre: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Comparateur actif: Sedation, no temperature device and low MAP
Continuous deep sedation for 36 hours, fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
Autre: Sédation profonde
Sédation profonde pendant au moins 36h
Autre: Contrôle de la fièvre sans appareil
Prise en charge de la fièvre en réanimation sans appareil
Autre: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Comparateur actif: Minimal sedation, temperature device and high MAP
Minimal sedation (and early extubation if possible), fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥85mmHg
Dispositif: Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
Autre: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Autre: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Comparateur actif: Minimal sedation, no temperature device and high MAP
Minimal sedation (and early extubation if possible), fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
Autre: Contrôle de la fièvre sans appareil
Prise en charge de la fièvre en réanimation sans appareil
Autre: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Autre: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Comparateur actif: Minimal sedation, temperature device and low MAP
Minimal sedation (and early extubation if possible), fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥65mmHg
Dispositif: Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
Autre: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Autre: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Comparateur actif: Minimal sedation, no temperature device and low MAP
Minimal sedation (and early extubation if possible), fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
Autre: Contrôle de la fièvre sans appareil
Prise en charge de la fièvre en réanimation sans appareil
Autre: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Autre: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Major adverse kidney event (MAKE)
Délai: 30 days
A composite endpoint of MAKE: death from any cause by day 30, initiation of RRT during the stay in the primary hospital or persistent renal dysfunction defined as final creatinine value ≥200 % of the baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) at the time of discharge from the primary hospital
30 days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Difference between baseline and the highest in-hospital creatinine
Délai: During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest in-hospital creatinine
During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
Difference between baseline and the last measured in-hospital creatinine
Délai: At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the last measured in-hospital creatinine (in the primary hospital)
At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
Difference between baseline and 72-hour creatinine
Délai: 72 hours
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and 72-hour creatinine
72 hours
Difference between baseline and the highest creatinine within 72 hours
Délai: 72 hours
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest creatinine within 72 hours
72 hours

Collaborateurs et enquêteurs

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

Parrainer

Helsinki University Central Hospital

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)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

28 avril 2026

Première soumission répondant aux critères de contrôle qualité

6 mai 2026

Première publication (Réel)

12 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STEPCARE-MAKE

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 .

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