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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 uppdaterad av: 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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

3500

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studieorter

  • 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
  • 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
  • Luxemburg
      • Luxembourg, Luxemburg
        • Centre Hospitalier de Luxembourg
  • Norge
      • Arendal, Norge
        • Soerlandet Hospital Arendal
      • Grålum, Norge
        • Kalnes Hospital
      • Oslo, Norge
        • Oslo University Hospital
      • Stavanger, Norge
        • Stavanger University Hospital
  • Nya Zeeland
      • Auckland, Nya Zeeland
        • DCCM ICU
      • Auckland, Nya Zeeland
        • Middlemore ICU
      • Auckland, Nya Zeeland
        • North Shore ICU NZ
      • Christchurch, Nya Zeeland
        • Christchurch Hospital
      • Wellington, Nya Zeeland
        • Wellington Hospital
  • Saudiarabien
      • Riyadh, Saudiarabien
        • 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
  • Storbritannien
      • Basildon, Storbritannien
        • Essex cardiothoracic centre
      • Bristol, Storbritannien
        • Bristol Royal Infirmary
      • Cardiff, Storbritannien
        • Cardiff University Hospital
      • Leeds, Storbritannien
        • Leeds General Infirmary
      • London, Storbritannien
        • St Bartholomew's Hospital
      • London, Storbritannien
        • St Georges University Hospital
      • London, Storbritannien
        • Kings College Hospita
  • Sverige
      • Gothenburg, Sverige
        • Sahlgrenska University Hospital
      • Halmstad, Sverige
        • Hallands hospital
      • Helsingborg, Sverige
        • Helsingborg Hospital
      • Karlstad, Sverige
        • Karlstad Hospital
      • Lund, Sverige
        • Skane University Hospital
      • Malmö, Sverige
        • Skåne University Hospital Malmö
      • 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

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

Beskrivning

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

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Faktoriell uppgift
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / 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
Övrig: Djup sedering
Djup sedering i minst 36 timmar
Enhet: 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
Övrig: 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
Övrig: Djup sedering
Djup sedering i minst 36 timmar
Övrig: Feberkontroll utan apparat
Hantering av feber på intensiven utan apparat
Övrig: 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
Övrig: Djup sedering
Djup sedering i minst 36 timmar
Enhet: 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
Övrig: 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
Övrig: Djup sedering
Djup sedering i minst 36 timmar
Övrig: Feberkontroll utan apparat
Hantering av feber på intensiven utan apparat
Övrig: 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
Enhet: 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
Övrig: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Övrig: 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
Övrig: Feberkontroll utan apparat
Hantering av feber på intensiven utan apparat
Övrig: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Övrig: 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
Enhet: 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
Övrig: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Övrig: 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
Övrig: Feberkontroll utan apparat
Hantering av feber på intensiven utan apparat
Övrig: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Övrig: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Major adverse kidney event (MAKE)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Difference between baseline and the highest in-hospital creatinine
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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

Sponsor

Helsinki University Central Hospital

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)

1 december 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

28 april 2026

Först inskickad som uppfyllde QC-kriterierna

6 maj 2026

Första postat (Faktisk)

12 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STEPCARE-MAKE

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Nej

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