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
Sites (52)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Prince Charles Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Nepean Hospital Coordinator of this site? Confirm its status | Kingswood | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Austin Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| The Sutherland Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| St George Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| HUB Hôpital Erasme Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg Hospital Coordinator of this site? Confirm its status | Lanaken | Belgium | Unknown status |
| Bern University Hospital Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| St Gallen Hospital Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Charité University Hospital Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Lübeck University Hospital Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Tübingen University Hospital Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| North Estonia Medical Centre Coordinator of this site? Confirm its status | Tallinn | Estonia | Unknown status |
| Jorvi Hospital Coordinator of this site? Confirm its status | Espoo | Finland | Unknown status |
| Meilahti Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Jyväskylä Hospital Coordinator of this site? Confirm its status | Jyväskylä | Finland | Unknown status |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Unknown status |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Unknown status |
| Essex Cardiothoracic Centre Coordinator of this site? Confirm its status | Basildon | United Kingdom | Unknown status |
| Bristol Royal Infirmary Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Cardiff University Hospital Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Leeds General Infirmary Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St Georges University Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Kings College Hospita Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| San Martino Hospital Genova Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Centre hospitalier de Luxembourg Coordinator of this site? Confirm its status | Luxembourg | Luxembourg | Unknown status |
| Soerlandet Hospital Arendal Coordinator of this site? Confirm its status | Arendal | Norway | Unknown status |
| Kalnes Hospital Coordinator of this site? Confirm its status | Grålum | Norway | Unknown status |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Stavanger University Hospital Coordinator of this site? Confirm its status | Stavanger | Norway | Unknown status |
| DCCM ICU Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Middlemore ICU Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| North Shore ICU NZ Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Wellington Hospital Coordinator of this site? Confirm its status | Wellington | New Zealand | Unknown status |
| King Abdulaziz Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Hallands Hospital Coordinator of this site? Confirm its status | Halmstad | Sweden | Unknown status |
| Helsingborg hospital Coordinator of this site? Confirm its status | Helsingborg | Sweden | Unknown status |
| Karlstad Hospital Coordinator of this site? Confirm its status | Karlstad | Sweden | Unknown status |
| Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| Skane University Hospital Malmö Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Skaraborg hospital Skövde Coordinator of this site? Confirm its status | Skövde | Sweden | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| University Hospital of Umeå Coordinator of this site? Confirm its status | Umeå | Sweden | Unknown status |
| Tan Tock Seng Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.