Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

NCT05564754 | Recruiting DMC

• 1 other identifier: step2022
• Study Type: interventional
• Target: 3,500
• Locations: 15 countries
• Sites: 56

Brief 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.

Conditions

Cardiac Arrest With Successful Resuscitation; Hypoxia, Brain

Outcome Measures

Primary Outcomes (1)

• Mortality

  Landmark mortality at follow-up performed at 6 months

  6 months

Secondary Outcomes (2)

• Functional outcome

  6 months

• Health-related quality of life

  6 months

Other Outcomes (2)

• ICU stay

  6 months

• Days at home within the first 30 days

  30 days

Study Arms (8)

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.

Device: Feedback-controlled temperature device; Other: High MAP; Other: Deep sedation

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.

Other: High MAP; Other: Deep sedation; Other: Fever control without a device

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.

Device: Feedback-controlled temperature device; Other: Deep sedation; Other: Low MAP

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.

Other: Deep sedation; Other: Fever control without a device; Other: Low MAP

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.

Device: Feedback-controlled temperature device; Other: High MAP; Other: Minimal sedation

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.

Other: High MAP; Other: Fever control without a device; Other: Minimal sedation

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.

Device: Feedback-controlled temperature device; Other: Low MAP; Other: Minimal sedation

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.

Other: Fever control without a device; Other: Low MAP; Other: Minimal sedation

Interventions

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.

Minimal sedation, temperature device and high MAP; Minimal sedation, temperature device and low MAP; Sedation, temperature device and high MAP; Sedation, temperature device and low MAP

High MAP OTHER

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

Minimal sedation, no temperature device and high MAP; Minimal sedation, temperature device and high MAP; Sedation, no temperature device and high MAP; Sedation, temperature device and high MAP

Deep sedation OTHER

Deep sedation for at least 36h

Sedation, no temperature device and high MAP; Sedation, no temperature device and low MAP; Sedation, temperature device and high MAP; Sedation, temperature device and low MAP

Fever control without a device OTHER

Management of fever in the ICU without a device

Minimal sedation, no temperature device and high MAP; Minimal sedation, no temperature device and low MAP; Sedation, no temperature device and high MAP; Sedation, no temperature device and low MAP

Low MAP OTHER

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

Minimal sedation, no temperature device and low MAP; Minimal sedation, temperature device and low MAP; Sedation, no temperature device and low MAP; Sedation, temperature device and low MAP

Minimal sedation OTHER

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

Minimal sedation, no temperature device and high MAP; Minimal sedation, no temperature device and low MAP; Minimal sedation, temperature device and high MAP; Minimal sedation, temperature device and low MAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out-of-hospital cardiac arrest
• Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
• 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.
• Eligible for intensive care without restrictions or limitations

You may not qualify if:

• On ECMO prior to randomization
• Pregnancy
• Suspected or confirmed intracranial hemorrhage
• Previously randomized in the STEPCARE trial
• Trauma or hemorrhage being the presumed cause of arrest

Sponsors & Collaborators

• Region Skane: lead
• Lund University, Lund, Sweden: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• The George Institute for Global Health, Australia: collaborator
• HUS Helsinki University Hospitals, Helsinki, Finland: collaborator
• Medical Research Institute of New Zealand Rangahautia Te Ora, Wellington, New Zealand: collaborator
• University Hospital of Wales: collaborator

Study Sites (56)

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, 1077, Belgium

RECRUITING

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

Ziekenhuis Oost-Limburg Hospital

Lanaken, 3620, Belgium

RECRUITING

North Estonia Medical Centre, Tallinn

Tallinn, 13409, Estonia

RECRUITING

Jorvi Hospital

Espoo, Finland

RECRUITING

Meilahti Hospital

Helsinki, 00290, 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

Malmo, 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

Bristol Royal Infirmary

Bristol, United Kingdom

RECRUITING

Cardiff University Hospital

Cardiff, United Kingdom

RECRUITING

Leeds General Infirmary

Leeds, United Kingdom

RECRUITING

Kings College Hospital

London, United Kingdom

RECRUITING

St Bartholomew's Hospital

London, United Kingdom

RECRUITING

St Georges University Hospital

London, United Kingdom

RECRUITING

Related Links

• Trial webpage

MeSH Terms

Conditions

Hypoxia, Brain

Interventions

Deep Sedation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Niklas Nielsen, PhD

  Lund University

  STUDY CHAIR

Central Study Contacts

Josef Dankiewicz, PhD

CONTACT

+464671000; josef.dankiewicz@med.lu.se

Niklas Nielsen, PhD

CONTACT

+46424061000; niklas.nielsen@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2x2 factorial, with all patients taking part in each factor.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: August 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-06

Locations

DE (3); SA (1); AU (8); IT (1); NO (4); FI (7); IE (1); SG (1); CH (3); BE (3); LU (1); NZ (6); SE (9); ES (1); GB (7)