Hypoxia, Brain Clinical Trial
— STEPCAREOfficial title:
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
NCT number | NCT05564754 |
Other study ID # | step2022 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 17, 2023 |
Est. completion date | June 2026 |
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.
Status | Recruiting |
Enrollment | 3500 |
Est. completion date | June 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Princess Alexandra Hospital | Brisbane | Queensland |
Australia | The Prince Charles Hospital | Brisbane | Queensland |
Australia | Northern Hospital | Epping | Victoria |
Australia | Nepean Hospital | Kingswood | New South Wales |
Australia | Liverpool Hospital | Liverpool | New South Wales |
Australia | Austin Hospital | Melbourne | Victoria |
Australia | The Victorian Heart Hospital | Melbourne | Victoria |
Australia | John Hunter Hospital | Newcastle | New South Wales |
Australia | Concord Repatriation Hospital | Sydney | New South Wales |
Australia | Royal North Shore Hospital | Sydney | New South Wales |
Australia | St George Hospital | Sydney | New South Wales |
Australia | The Sutherland Hospital | Sydney | New South Wales |
Australia | Westmead Hospital | Westmead | New South Wales |
Finland | Jorvi Hospital | Espoo | |
Finland | Helsinki Helsingforgs University Central Hospital | Helsinki | |
Finland | Kuopio University Hospital | Kuopio | |
Finland | Oulu University Hospital | Oulu | |
Finland | Tampere University Hospital | Tampere | |
Germany | Lübeck University Hospital | Lübeck | |
Luxembourg | Centre Hospitalier de Luxembourg | Luxembourg | |
New Zealand | Christchurch Hospital | Christchurch | |
New Zealand | Wellington Hospital | Wellington | |
Sweden | Sahlgrenska University Hospital | Gothenburg | |
Sweden | Hallands hospital | Halmstad | Halland |
Sweden | Helsingborg Hospital | Helsingborg | Skåne |
Sweden | Skåne University Hospital | Lund | Skåne |
Sweden | Skåne University Hospital Malmö | Malmö | Skåne |
Sweden | Karolinska University Hospital | Solna | |
Switzerland | St Gallen Hospital | Saint Gallen | |
Switzerland | University Hospital Zürich | Zürich |
Lead Sponsor | Collaborator |
---|---|
Region Skane | Copenhagen Trial Unit, Center for Clinical Intervention Research, HUS Helsinki University Hospitals, Helsinki, Finland, Lund University, Lund, Sweden, Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand, The George Institute for Global Health, Australia |
Australia, Finland, Germany, Luxembourg, New Zealand, Sweden, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ICU stay | Length of stay for ICU survivors | 6 months | |
Other | Days at home within the first 30 days | Days outside of hospital within the first 30 days | 30 days | |
Primary | Mortality | Landmark mortality at follow-up performed at 6 months | 6 months | |
Secondary | Functional outcome | Proportion of patients who have a mRS score of 4-6 | 6 months | |
Secondary | Health-related quality of life | EQ5D-5L VAS | 6 months |
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