Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

NCT05564754 | Active Not 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

Hypoxia, Brain; Cardiac Arrest With Successful Resuscitation

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
• 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
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (56)

Nepean Hospital

Kingswood, New South Wales, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, Australia

Location

St George Hospital

Sydney, New South Wales, Australia

Location

The Sutherland Hospital

Sydney, New South Wales, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Location

The Prince Charles Hospital

Brisbane, Queensland, Australia

Location

Austin Hospital

Melbourne, Victoria, Australia

Location

HUB Hôpital Erasme

Brussels, 1077, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

Ziekenhuis Oost-Limburg Hospital

Lanaken, 3620, Belgium

Location

North Estonia Medical Centre, Tallinn

Tallinn, 13409, Estonia

Location

Jorvi Hospital

Espoo, Finland

Location

Meilahti Hospital

Helsinki, 00290, Finland

Location

Helsinki Helsingforgs University Central Hospital

Helsinki, Finland

Location

Jyväskylä Hospital

Jyväskylä, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Charite University Hospital

Berlin, Germany

Location

Lübeck University Hospital

Lübeck, Germany

Location

Tubingen University Hospital

Tübingen, Germany

Location

St Vincents University Hospital

Dublin, Ireland

Location

San Martino Hospital Genova

Genova, Italy

Location

Centre Hospitalier de Luxembourg

Luxembourg, Luxembourg

Location

DCCM ICU

Auckland, New Zealand

Location

Middlemore ICU

Auckland, New Zealand

Location

North Shore ICU NZ

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Whangarei ICU

Northland, New Zealand

Location

Wellington Hospital

Wellington, New Zealand

Location

Soerlandet Hospital Arendal

Arendal, Norway

Location

Kalnes Hospital

Kalnes, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

King Abdulaziz Medical City

Riyadh, Saudi Arabia

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Hallands hospital

Halmstad, Halland County, Sweden

Location

Helsingborg Hospital

Helsingborg, Skåne County, Sweden

Location

Skåne University Hospital

Lund, Skåne County, Sweden

Location

Skåne University Hospital Malmö

Malmö, Skåne County, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Karlstad hospital

Karlstad, Sweden

Location

Skaraborg Hospital Skovde

Skövde, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

University Hospital of Umeå

Umeå, Sweden

Location

Bern University Hospital

Bern, Switzerland

Location

St Gallen Hospital

Sankt Gallen, Switzerland

Location

University Hospital Zürich

Zurich, Switzerland

Location

Essex Cardiothoracic Centre

Basildon, United Kingdom

Location

Bristol Royal Infirmary

Bristol, United Kingdom

Location

Cardiff University Hospital

Cardiff, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

St Georges University Hospital

London, United Kingdom

Location

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

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): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

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)