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Clinical Trials in Belgium / NCT05564754
Active, not recruiting Not applicable

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

NCT05564754 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2023-08-17
Last updated
2026-06-02

Condition(s) studied

Cardiac Arrest With Successful ResuscitationHypoxia, Brain

Investigational drug(s) / intervention(s)

Feedback-controlled temperature deviceHigh MAPDeep sedationFever control without a deviceLow MAPMinimal sedation

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.

High MAP: A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.

Deep sedation: Deep sedation for at least 36h

Fever control without a device: Management of fever in the ICU without a device

Low MAP: A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h.

Minimal sedation: A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures.

Study summary

The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Out-of-hospital cardiac arrest 2. Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions 3. Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of \<4) or being intubated and sedated because of agitation after sustained ROSC. 4. Eligible for intensive care without restrictions or limitations 5. Inclusion within 4 hours of ROSC Exclusion Criteria: 1. On ECMO prior to randomization 2. Pregnancy 3. Suspected or confirmed intracranial hemorrhage 4. Previously randomized in the STEPCARE trial 5. Trauma or hemorrhage being the presumed cause of arrest

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
Nepean Hospital Kingswood New South Wales
Liverpool Hospital Liverpool New South Wales
Royal North Shore Hospital Sydney New South Wales
St George Hospital Sydney New South Wales
The Sutherland Hospital Sydney New South Wales
Princess Alexandra Hospital Brisbane Queensland
The Prince Charles Hospital Brisbane Queensland
Austin Hospital Melbourne Victoria
HUB Hôpital Erasme Brussels Belgium
Ghent University Hospital Ghent Belgium
Ziekenhuis Oost-Limburg Hospital Lanaken Belgium
North Estonia Medical Centre, Tallinn Tallinn Estonia
Jorvi Hospital Espoo Finland
Meilahti Hospital Helsinki Finland
Helsinki Helsingforgs University Central Hospital Helsinki Finland
Jyväskylä Hospital Jyväskylä Finland
Kuopio University Hospital Kuopio Finland
Oulu University Hospital Oulu Finland
Tampere University Hospital Tampere Finland
Charite University Hospital Berlin Germany
Lübeck University Hospital Lübeck Germany
Tubingen University Hospital Tübingen Germany
St Vincents University Hospital Dublin Ireland
San Martino Hospital Genova Genova Italy
Centre Hospitalier de Luxembourg Luxembourg Luxembourg
DCCM ICU Auckland New Zealand
Middlemore ICU Auckland New Zealand
North Shore ICU NZ Auckland New Zealand
Christchurch Hospital Christchurch New Zealand
Whangarei ICU Northland New Zealand
Wellington Hospital Wellington New Zealand
Soerlandet Hospital Arendal Arendal Norway
Kalnes Hospital Kalnes Norway
Oslo University Hospital Oslo Norway
Stavanger University Hospital Stavanger Norway
King Abdulaziz Medical City Riyadh Saudi Arabia
Tan Tock Seng Hospital Singapore Singapore
Hallands hospital Halmstad Halland County
Helsingborg Hospital Helsingborg Skåne County
Skåne University Hospital Lund Skåne County

+ 16 more sites — see the full list on the official registry below.

More Region Skane trials in Belgium

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05564754 on ClinicalTrials.gov ↗ ← All trials in Belgium