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NCT07579390Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
3500 (estimated)
First submitted
28 Apr 2026
Start date
17 Aug 2023
Primary completion date
Dec 2026
Lead sponsor
Helsinki University Central Hospital
NCT number
NCT07579390

What you commit to

  • Study type: Interventional
  • Planned participants: 3500
  • From 17 Aug 2023 to the primary completion date, Dec 2026
  • 52 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Extracorporeal membrane oxygenation (ECMO) prior to randomization

Other illness

  • Out-of-hospital cardiac arrest of presumed traumatic or hemorrhagic origin
  • Confirmed or suspected intracranial hemorrhage

Other

  • Pregnancy
  • No additional exclusion criteria are applied beyond those of the main STEPCARE trial

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (52)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Prince Charles Hospital
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BrisbaneAustraliaUnknown status
Princess Alexandra Hospital
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BrisbaneAustraliaUnknown status
Nepean Hospital
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KingswoodAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
Austin Hospital
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MelbourneAustraliaUnknown status
Royal North Shore Hospital
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SydneyAustraliaUnknown status
The Sutherland Hospital
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SydneyAustraliaUnknown status
St George Hospital
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SydneyAustraliaUnknown status
HUB Hôpital Erasme
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BrusselsBelgiumUnknown status
Ghent university hospital
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GhentBelgiumUnknown status
Ziekenhuis Oost-Limburg Hospital
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LanakenBelgiumUnknown status
Bern University Hospital
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BernSwitzerlandUnknown status
St Gallen Hospital
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Sankt GallenSwitzerlandUnknown status
University Hospital Zurich
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ZurichSwitzerlandUnknown status
Charité University Hospital
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BerlinGermanyUnknown status
Lübeck University Hospital
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LübeckGermanyUnknown status
Tübingen University Hospital
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TübingenGermanyUnknown status
North Estonia Medical Centre
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TallinnEstoniaUnknown status
Jorvi Hospital
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EspooFinlandUnknown status
Meilahti Hospital
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HelsinkiFinlandUnknown status
Jyväskylä Hospital
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JyväskyläFinlandUnknown status
Kuopio University Hospital
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KuopioFinlandUnknown status
Oulu University Hospital
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OuluFinlandUnknown status
Essex Cardiothoracic Centre
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BasildonUnited KingdomUnknown status
Bristol Royal Infirmary
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BristolUnited KingdomUnknown status
Cardiff University Hospital
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CardiffUnited KingdomUnknown status
Leeds General Infirmary
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LeedsUnited KingdomUnknown status
St. Bartholomew's Hospital
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LondonUnited KingdomUnknown status
St Georges University Hospital
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LondonUnited KingdomUnknown status
Kings College Hospita
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LondonUnited KingdomUnknown status
San Martino Hospital Genova
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GenovaItalyUnknown status
Centre hospitalier de Luxembourg
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LuxembourgLuxembourgUnknown status
Soerlandet Hospital Arendal
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ArendalNorwayUnknown status
Kalnes Hospital
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GrålumNorwayUnknown status
Oslo University Hospital
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OsloNorwayUnknown status
Stavanger University Hospital
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StavangerNorwayUnknown status
DCCM ICU
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AucklandNew ZealandUnknown status
Middlemore ICU
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AucklandNew ZealandUnknown status
North Shore ICU NZ
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AucklandNew ZealandUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Wellington Hospital
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WellingtonNew ZealandUnknown status
King Abdulaziz Medical City
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RiyadhSaudi ArabiaUnknown status
Sahlgrenska University Hospital
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GothenburgSwedenUnknown status
Hallands Hospital
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HalmstadSwedenUnknown status
Helsingborg hospital
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HelsingborgSwedenUnknown status
Karlstad Hospital
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KarlstadSwedenUnknown status
Skåne University Hospital
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LundSwedenUnknown status
Skane University Hospital Malmö
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MalmöSwedenUnknown status
Skaraborg hospital Skövde
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SkövdeSwedenUnknown status
Karolinska University Hospital
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StockholmSwedenUnknown status
University Hospital of Umeå
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UmeåSwedenUnknown status
Tan Tock Seng Hospital
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SingaporeSingaporeUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.