Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07579390

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

Led by Helsinki University Central Hospital · Updated on 2026-05-14

3500

Participants Needed

52

Research Sites

171 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients included in the main STEPCARE trial are also included in this sub-study
  • Out-of-hospital cardiac arrest
  • Sustained return of spontaneous circulation for at least 20 minutes without chest compressions
  • Unconsciousness defined as FOUR-score motor response less than 4, inability to obey verbal commands, or intubated and sedated due to agitation
  • Eligible for intensive care without restrictions or limitations
  • Inclusion within 4 hours of return of spontaneous circulation
Not Eligible

You will not qualify if you...

  • 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 beyond those of the main STEPCARE trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 52 locations

1

Princess Alexandra Hospital

Brisbane, Australia

Actively Recruiting

2

The Prince Charles Hospital

Brisbane, Australia

Actively Recruiting

3

Nepean Hospital

Kingswood, Australia

Actively Recruiting

4

Liverpool Hospital

Liverpool, Australia

Actively Recruiting

5

Austin Hospital

Melbourne, Australia

Actively Recruiting

6

Royal North Shore Hospital

Sydney, Australia

Actively Recruiting

7

St George Hospital

Sydney, Australia

Actively Recruiting

8

The Sutherland Hospital

Sydney, Australia

Actively Recruiting

9

HUB Hôpital Erasme

Brussels, Belgium

Actively Recruiting

10

Ghent University Hospital

Ghent, Belgium

Actively Recruiting

11

Ziekenhuis Oost-Limburg Hospital

Lanaken, Belgium

Actively Recruiting

12

North Estonia Medical Centre

Tallinn, Estonia

Actively Recruiting

13

Jorvi Hospital

Espoo, Finland

Actively Recruiting

14

Meilahti Hospital

Helsinki, Finland, 00290

Actively Recruiting

15

Jyväskylä Hospital

Jyväskylä, Finland

Actively Recruiting

16

Kuopio University Hospital

Kuopio, Finland

Actively Recruiting

17

Oulu University Hospital

Oulu, Finland

Actively Recruiting

18

Charite University Hospital

Berlin, Germany

Actively Recruiting

19

Lübeck University Hospital

Lübeck, Germany

Actively Recruiting

20

Tubingen University Hospital

Tübingen, Germany

Actively Recruiting

21

San Martino Hospital Genova

Genova, Italy

Actively Recruiting

22

Centre Hospitalier de Luxembourg

Luxembourg, Luxembourg

Actively Recruiting

23

DCCM ICU

Auckland, New Zealand

Actively Recruiting

24

Middlemore ICU

Auckland, New Zealand

Actively Recruiting

25

North Shore ICU NZ

Auckland, New Zealand

Actively Recruiting

26

Christchurch Hospital

Christchurch, New Zealand

Actively Recruiting

27

Wellington Hospital

Wellington, New Zealand

Actively Recruiting

28

Soerlandet Hospital Arendal

Arendal, Norway

Actively Recruiting

29

Kalnes Hospital

Grålum, Norway

Actively Recruiting

30

Oslo University Hospital

Oslo, Norway

Actively Recruiting

31

Stavanger University Hospital

Stavanger, Norway

Actively Recruiting

32

King Abdulaziz Medical City

Riyadh, Saudi Arabia

Actively Recruiting

33

Tan Tock Seng Hospital

Singapore, Singapore

Actively Recruiting

34

Sahlgrenska University Hospital

Gothenburg, Sweden

Actively Recruiting

35

Hallands hospital

Halmstad, Sweden

Actively Recruiting

36

Helsingborg Hospital

Helsingborg, Sweden

Actively Recruiting

37

Karlstad hospital

Karlstad, Sweden

Actively Recruiting

38

Skåne University Hospital

Lund, Sweden

Actively Recruiting

39

Skåne University Hospital Malmö

Malmö, Sweden

Actively Recruiting

40

Skaraborg Hospital Skovde

Skövde, Sweden

Actively Recruiting

41

Karolinska University Hospital

Stockholm, Sweden

Actively Recruiting

42

University Hospital of Umeå

Umeå, Sweden

Actively Recruiting

43

Bern University Hospital

Bern, Switzerland

Actively Recruiting

44

St Gallen Hospital

Sankt Gallen, Switzerland

Actively Recruiting

45

University Hospital Zürich

Zurich, Switzerland

Actively Recruiting

46

Essex Cardiothoracic Centre

Basildon, United Kingdom

Actively Recruiting

47

Bristol Royal Infirmary

Bristol, United Kingdom

Actively Recruiting

48

Cardiff University Hospital

Cardiff, United Kingdom

Actively Recruiting

49

Leeds General Infirmary

Leeds, United Kingdom

Actively Recruiting

50

Kings College Hospita

London, United Kingdom

Actively Recruiting

51

St Bartholomew's Hospital

London, United Kingdom

Actively Recruiting

52

St Georges University Hospital

London, United Kingdom

Actively Recruiting

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Research Team

M

Markus B Skrifvars, Prof

CONTACT

M

Miikka Keski-Keturi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

8

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