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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. maj 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

3500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
      • Brisbane, Australien
        • Princess Alexandra Hospital
      • Brisbane, Australien
        • The Prince Charles Hospital
      • Kingswood, Australien
        • Nepean Hospital
      • Liverpool, Australien
        • Liverpool Hospital
      • Melbourne, Australien
        • Austin Hospital
      • Sydney, Australien
        • Royal North Shore Hospital
      • Sydney, Australien
        • St George Hospital
      • Sydney, Australien
        • The Sutherland Hospital
  • Belgien
      • Brussels, Belgien
        • HUB Hôpital Erasme
      • Ghent, Belgien
        • Ghent University Hospital
      • Lanaken, Belgien
        • Ziekenhuis Oost-Limburg Hospital
  • Det Forenede Kongerige
      • Basildon, Det Forenede Kongerige
        • Essex Cardiothoracic Centre
      • Bristol, Det Forenede Kongerige
        • Bristol Royal Infirmary
      • Cardiff, Det Forenede Kongerige
        • Cardiff University Hospital
      • Leeds, Det Forenede Kongerige
        • Leeds General Infirmary
      • London, Det Forenede Kongerige
        • St Bartholomew's Hospital
      • London, Det Forenede Kongerige
        • St Georges University Hospital
      • London, Det Forenede Kongerige
        • Kings College Hospita
  • Estland
      • Tallinn, Estland
        • North Estonia Medical Centre
  • Finland
      • Espoo, Finland
        • Jorvi Hospital
      • Helsinki, Finland, 00290
        • Meilahti Hospital
      • Jyväskylä, Finland
        • Jyväskylä Hospital
      • Kuopio, Finland
        • Kuopio University Hospital
      • Oulu, Finland
        • Oulu University Hospital
  • Italien
      • Genova, Italien
        • San Martino Hospital Genova
  • Luxembourg
      • Luxembourg, Luxembourg
        • Centre Hospitalier de Luxembourg
  • New Zealand
      • Auckland, New Zealand
        • DCCM ICU
      • Auckland, New Zealand
        • Middlemore ICU
      • Auckland, New Zealand
        • North Shore ICU NZ
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Wellington, New Zealand
        • Wellington Hospital
  • Norge
      • Arendal, Norge
        • Soerlandet Hospital Arendal
      • Grålum, Norge
        • Kalnes Hospital
      • Oslo, Norge
        • Oslo University Hospital
      • Stavanger, Norge
        • Stavanger University Hospital
  • Saudi Arabien
      • Riyadh, Saudi Arabien
        • King Abdulaziz Medical City
  • Schweiz
      • Bern, Schweiz
        • Bern University Hospital
      • Sankt Gallen, Schweiz
        • St Gallen Hospital
      • Zurich, Schweiz
        • University Hospital Zurich
  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital
  • Sverige
      • Gothenburg, Sverige
        • Sahlgrenska University Hospital
      • Halmstad, Sverige
        • Hallands hospital
      • Helsingborg, Sverige
        • Helsingborg Hospital
      • Karlstad, Sverige
        • Karlstad hospital
      • Lund, Sverige
        • Skåne University Hospital
      • Malmö, Sverige
        • Skane University Hospital Malmo
      • Skövde, Sverige
        • Skaraborg Hospital Skovde
      • Stockholm, Sverige
        • Karolinska University Hospital
      • Umeå, Sverige
        • University Hospital of Umeå
  • Tyskland
      • Berlin, Tyskland
        • Charite University Hospital
      • Lübeck, Tyskland
        • Lübeck University Hospital
      • Tübingen, Tyskland
        • Tubingen University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Andet: Dyb sedation
Dyb sedation i mindst 36 timer
Enhed: 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
Andet: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Aktiv komparator: 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
Andet: Dyb sedation
Dyb sedation i mindst 36 timer
Andet: Feberkontrol uden en enhed
Håndtering af feber på intensivafdelingen uden en enhed
Andet: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Aktiv komparator: 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
Andet: Dyb sedation
Dyb sedation i mindst 36 timer
Enhed: 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
Andet: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Aktiv komparator: 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
Andet: Dyb sedation
Dyb sedation i mindst 36 timer
Andet: Feberkontrol uden en enhed
Håndtering af feber på intensivafdelingen uden en enhed
Andet: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Aktiv komparator: 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
Enhed: 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
Andet: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Andet: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Aktiv komparator: 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
Andet: Feberkontrol uden en enhed
Håndtering af feber på intensivafdelingen uden en enhed
Andet: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Andet: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Aktiv komparator: 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
Enhed: 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
Andet: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Andet: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Aktiv komparator: 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
Andet: Feberkontrol uden en enhed
Håndtering af feber på intensivafdelingen uden en enhed
Andet: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Andet: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major adverse kidney event (MAKE)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference between baseline and the highest in-hospital creatinine
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Helsinki University Central Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. august 2023

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STEPCARE-MAKE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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