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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 oppdatert 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

3500

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
      • Brisbane, Australia
        • Princess Alexandra Hospital
      • Brisbane, Australia
        • The Prince Charles Hospital
      • Kingswood, Australia
        • Nepean Hospital
      • Liverpool, Australia
        • Liverpool Hospital
      • Melbourne, Australia
        • Austin Hospital
      • Sydney, Australia
        • Royal North Shore Hospital
      • Sydney, Australia
        • St George Hospital
      • Sydney, Australia
        • The Sutherland Hospital
  • Belgia
      • Brussels, Belgia
        • HUB Hôpital Erasme
      • Ghent, Belgia
        • Ghent University Hospital
      • Lanaken, Belgia
        • 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
  • Italia
      • Genova, Italia
        • 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-Arabia
      • Riyadh, Saudi-Arabia
        • King Abdulaziz Medical City
  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital
  • Storbritannia
      • Basildon, Storbritannia
        • Essex cardiothoracic centre
      • Bristol, Storbritannia
        • Bristol Royal Infirmary
      • Cardiff, Storbritannia
        • Cardiff University Hospital
      • Leeds, Storbritannia
        • Leeds General Infirmary
      • London, Storbritannia
        • St Bartholomew's Hospital
      • London, Storbritannia
        • St Georges University Hospital
      • London, Storbritannia
        • Kings College Hospita
  • Sveits
      • Bern, Sveits
        • Bern University Hospital
      • Sankt Gallen, Sveits
        • St Gallen Hospital
      • Zurich, Sveits
        • University Hospital Zurich
  • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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
Annen: Dyp sedasjon
Dyp sedasjon i minst 36 timer
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
Annen: 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
Annen: Dyp sedasjon
Dyp sedasjon i minst 36 timer
Annen: Feberkontroll uten enhet
Behandling av feber på intensivavdelingen uten utstyr
Annen: 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
Annen: Dyp sedasjon
Dyp sedasjon i minst 36 timer
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
Annen: 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
Annen: Dyp sedasjon
Dyp sedasjon i minst 36 timer
Annen: Feberkontroll uten enhet
Behandling av feber på intensivavdelingen uten utstyr
Annen: 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
Annen: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Annen: 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
Annen: Feberkontroll uten enhet
Behandling av feber på intensivavdelingen uten utstyr
Annen: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Annen: 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
Annen: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Annen: 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
Annen: Feberkontroll uten enhet
Behandling av feber på intensivavdelingen uten utstyr
Annen: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Annen: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Helsinki University Central Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. august 2023

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

6. mai 2026

Først lagt ut (Faktiske)

12. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STEPCARE-MAKE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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