Managing sedation, temperature, and blood pressure after cardiac arrest
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation
NA · Region Skane · NCT05564754
This study tests how different levels of sedation, temperature control, and blood pressure management can help people who have survived cardiac arrest and are in a coma to survive longer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane (other) |
| Locations | 56 sites (Kingswood, New South Wales and 55 other locations) |
| Trial ID | NCT05564754 on ClinicalTrials.gov |
What this trial studies
The STEPCARE-trial is a randomized trial involving 3500 patients who have been resuscitated from cardiac arrest and are in a comatose state. It investigates three different interventions: sedation levels, temperature management, and blood pressure targets. Participants will be assigned to either control or intervention groups for each of these parameters, with follow-ups at 30 days and 6 months to assess survival outcomes. The primary goal is to determine the impact of these interventions on survival rates at 6 months post-resuscitation.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced out-of-hospital cardiac arrest and are comatose after successful resuscitation.
Not a fit: Patients on ECMO prior to randomization or those with suspected intracranial hemorrhage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and neurological outcomes for patients resuscitated from cardiac arrest.
How similar studies have performed: Other studies have explored similar interventions in post-cardiac arrest care, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kingswood, New South Wales and 55 other locations
- Nepean Hospital — Kingswood, New South Wales, Australia (RECRUITING)
- Liverpool Hospital — Liverpool, New South Wales, Australia (RECRUITING)
- Royal North Shore Hospital — Sydney, New South Wales, Australia (RECRUITING)
- St George Hospital — Sydney, New South Wales, Australia (RECRUITING)
- The Sutherland Hospital — Sydney, New South Wales, Australia (RECRUITING)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (RECRUITING)
- The Prince Charles Hospital — Brisbane, Queensland, Australia (RECRUITING)
- Austin Hospital — Melbourne, Victoria, Australia (RECRUITING)
- HUB Hôpital Erasme — Brussels, Belgium (RECRUITING)
- Ghent University Hospital — Ghent, Belgium (RECRUITING)
- Ziekenhuis Oost-Limburg Hospital — Lanaken, Belgium (RECRUITING)
- North Estonia Medical Centre, Tallinn — Tallinn, Estonia (RECRUITING)
- Jorvi Hospital — Espoo, Finland (RECRUITING)
- Meilahti Hospital — Helsinki, Finland (RECRUITING)
- Helsinki Helsingforgs University Central Hospital — Helsinki, Finland (RECRUITING)
- Jyväskylä Hospital — Jyväskylä, Finland (RECRUITING)
- Kuopio University Hospital — Kuopio, Finland (RECRUITING)
- Oulu University Hospital — Oulu, Finland (RECRUITING)
- Tampere University Hospital — Tampere, Finland (RECRUITING)
- Charite University Hospital — Berlin, Germany (RECRUITING)
- Lübeck University Hospital — Lübeck, Germany (RECRUITING)
- Tubingen University Hospital — Tübingen, Germany (RECRUITING)
- St Vincents University Hospital — Dublin, Ireland (ACTIVE_NOT_RECRUITING)
- San Martino Hospital Genova — Genova, Italy (RECRUITING)
- Centre Hospitalier de Luxembourg — Luxembourg, Luxembourg (RECRUITING)
- DCCM ICU — Auckland, New Zealand (RECRUITING)
- Middlemore ICU — Auckland, New Zealand (RECRUITING)
- North Shore ICU NZ — Auckland, New Zealand (RECRUITING)
- Christchurch Hospital — Christchurch, New Zealand (RECRUITING)
- Whangarei ICU — Northland, New Zealand (ACTIVE_NOT_RECRUITING)
- Wellington Hospital — Wellington, New Zealand (RECRUITING)
- Soerlandet Hospital Arendal — Arendal, Norway (RECRUITING)
- Kalnes Hospital — Kalnes, Norway (RECRUITING)
- Oslo University Hospital — Oslo, Norway (RECRUITING)
- Stavanger University Hospital — Stavanger, Norway (RECRUITING)
- King Abdulaziz Medical City — Riyadh, Saudi Arabia (RECRUITING)
- Tan Tock Seng Hospital — Singapore, Singapore (RECRUITING)
- Hallands hospital — Halmstad, Halland County, Sweden (RECRUITING)
- Helsingborg Hospital — Helsingborg, Skåne County, Sweden (RECRUITING)
- Skåne University Hospital — Lund, Skåne County, Sweden (RECRUITING)
- Skåne University Hospital Malmö — Malmö, Skåne County, Sweden (RECRUITING)
- Sahlgrenska University Hospital — Gothenburg, Sweden (RECRUITING)
- Karlstad hospital — Karlstad, Sweden (RECRUITING)
- Skaraborg Hospital Skovde — Skövde, Sweden (RECRUITING)
- Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
- University Hospital of Umeå — Umeå, Sweden (RECRUITING)
- Bern University Hospital — Bern, Switzerland (RECRUITING)
- St Gallen Hospital — Sankt Gallen, Switzerland (RECRUITING)
- University Hospital Zürich — Zurich, Switzerland (RECRUITING)
- Essex Cardiothoracic Centre — Basildon, United Kingdom (RECRUITING)
+6 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Josef Dankiewicz, PhD
- Email: josef.dankiewicz@med.lu.se
- Phone: +464671000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain