Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lund University, Lund, Sweden | UNKNOWN |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
| The George Institute for Global Health, Australia | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
3500 patients who are comatose after cardiac arrest will be included in a trial studying three separate targets. All patients will be randomised to a control or an intervention arm for sedation, temperature and blood pressure targets. These are.
Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation, temperature device and high MAP | Active Comparator | Continuous deep sedation for 36 hours Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >85mmHg. |
|
| Sedation, no temperature device and high MAP | Active Comparator | Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >85mmHg. |
|
| Sedation, temperature device and low MAP | Active Comparator | Continuous deep sedation for 36 hours. Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >65mmHg. |
|
| Sedation, no temperature device and low MAP | Active Comparator | Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedback-controlled temperature device | Device | If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Landmark mortality at follow-up performed at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome | Proportion of patients who have a mRS score of 4-6 | 6 months |
| Health-related quality of life | EQ5D-5L VAS | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ICU stay | Length of stay for ICU survivors | 6 months |
| Days at home within the first 30 days | Days outside of hospital within the first 30 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Niklas Nielsen, PhD | Lund University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nepean Hospital | Kingswood | New South Wales | Australia | |||
| Liverpool Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42297460 | Derived | Battaglini D, Gualdi F, Cammarota G, McGuigan PJ, Thomas M, Skrifvars MB, Niemela VH, Reinikainen M, Bass F, Young PJ, Lilja G, Dankiewicz J, Hammond NE, Hastbacka J, Levin H, Moseby-Knappe M, Saxena M, Tiainen M, Kamp CB, Sillassen CDB, During J, Romundstad LG, Pascal S, Leithner C, Wise MP, Haenggi M, Cole J, Riddell J, Jakobsen JC, Nielsen N, Patroniti NA, Robba C. Ventilation strategies and outcomes after out-of-hospital cardiac arrest: protocol for a pre-planned sub-analysis of the STEPCARE trial. BMJ Open. 2026 Jun 15;16(6):e118872. doi: 10.1136/bmjopen-2026-118872. |
| Label | URL |
|---|---|
| Trial webpage | View source |
Not provided
Upon reasonable request following publication
Not provided
Not provided
Not provided
Not provided
Not provided
| HUS Helsinki University Hospitals, Helsinki, Finland |
| UNKNOWN |
| Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand | UNKNOWN |
| University Hospital of Wales | OTHER |
2x2x2 factorial, with all patients taking part in each factor.
Not provided
Not provided
Participants will be blinded. Assessors of neurological prognosis will be blinded. Outcome assessors and investigators will be blinded. Health-care personnel will not be blinded.
| Minimal sedation, temperature device and high MAP |
| Active Comparator |
Minimal sedation (and early extubation if possible). Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >85mmHg. |
|
| Minimal sedation, no temperature device and high MAP | Active Comparator | Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg. |
|
| Minimal sedation, temperature device and low MAP | Active Comparator | Minimal sedation (and early extubation if possible). Fever management with a feedback-controlled device if temperature above 37.7°C. A mean arterial pressure target of >65mmHg. |
|
| Minimal sedation, no temperature device and low MAP | Active Comparator | Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of >65mmHg. |
|
| High MAP | Other | A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h. |
|
| Deep sedation | Other | Deep sedation for at least 36h |
|
| Fever control without a device | Other | Management of fever in the ICU without a device |
|
| Low MAP | Other | A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h. |
|
| Minimal sedation | Other | A strategy of minimal sedation in the ICU, used only as needed to facilitate transport, imaging and invasive procedures. |
|
| 30 days |
| Liverpool |
| 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 |
| Princess Alexandra Hospital | Brisbane | Queensland | Australia |
| The Prince Charles Hospital | Brisbane | Queensland | Australia |
| Austin Hospital | Melbourne | Victoria | Australia |
| HUB Hôpital Erasme | Brussels | 1077 | Belgium |
| Ghent University Hospital | Ghent | 9000 | Belgium |
| Ziekenhuis Oost-Limburg Hospital | Lanaken | 3620 | Belgium |
| North Estonia Medical Centre, Tallinn | Tallinn | 13409 | Estonia |
| Jorvi Hospital | Espoo | Finland |
| Meilahti Hospital | Helsinki | 00290 | 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 | Sweden |
| Helsingborg Hospital | Helsingborg | Skåne County | Sweden |
| Skåne University Hospital | Lund | Skåne County | Sweden |
| Skåne University Hospital Malmö | Malmö | Skåne County | Sweden |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| Karlstad hospital | Karlstad | Sweden |
| Skaraborg Hospital Skovde | Skövde | Sweden |
| Karolinska University Hospital | Stockholm | Sweden |
| University Hospital of Umeå | Umeå | Sweden |
| Bern University Hospital | Bern | Switzerland |
| St Gallen Hospital | Sankt Gallen | Switzerland |
| University Hospital Zürich | Zurich | Switzerland |
| Essex Cardiothoracic Centre | Basildon | United Kingdom |
| Bristol Royal Infirmary | Bristol | United Kingdom |
| Cardiff University Hospital | Cardiff | United Kingdom |
| Leeds General Infirmary | Leeds | United Kingdom |
| Kings College Hospital | London | United Kingdom |
| St Bartholomew's Hospital | London | United Kingdom |
| St Georges University Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D002534 | Hypoxia, Brain |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D054810 | Deep Sedation |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided