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Active, Not Recruiting

NCT Number: NCT05564754

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Arrest With Successful Resuscitation Brain Diseases Central Nervous System Diseases Hypoxia Hypoxia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nepean Hospital, Kingswood, New South Wales, Australia

Loading trial locations.

About this study

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.

  • Continuous deep sedation for 36 hours or minimal sedation (SEDCARE)
  • Fever management with or without a feedback-controlled device (TEMPCARE)
  • A mean arterial pressure target of >85mmHg or >65mmHg. (MAPCARE)

Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Inclusion within 4 hours of ROSC

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Mortality

    Time frame: 6 months

    Landmark mortality at follow-up performed at 6 months

Secondary outcomes

  1. Functional outcome

    Time frame: 6 months

    Proportion of patients who have a mRS score of 4-6

  2. Health-related quality of life

    Time frame: 6 months

    EQ5D-5L VAS

Other outcomes

  1. ICU stay

    Time frame: 6 months

    Length of stay for ICU survivors

  2. Days at home within the first 30 days

    Time frame: 30 days

    Days outside of hospital within the first 30 days

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • 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
  • University Hospital of Wales

Registry information

Acronym: STEPCARE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2022
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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