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Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

RECRUITING

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.

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Study details:

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.

1. Continuous deep sedation for 36 hours or minimal sedation (SEDCARE). 2.

Fever management with or without a feedback-controlled device (TEMPCARE). 3. 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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-08-17

    Primary completion: 2025-12-01

    Study completion finish: 2026-06-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05564754

    Intervention or treatment

    DEVICE: Feedback-controlled temperature device

    OTHER: High MAP

    OTHER: Deep sedation

    OTHER: Fever control without a device

    OTHER: Low MAP

    OTHER: Minimal sedation

    Conditions

    • Cardiac Arrest With Successful Resuscitation
    • Hypoxia, Brain
    Image related to Cardiac Arrest With Successful Resuscitation
    • Condition: Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain

    • DEVICE: Feedback-controlled temperature device and other drugs

    • Newcastle, New South Wales, Australia and more

    • Sponsor: Region Skane

    Find a site

    Closest Location:

    John Hunter Hospital

    Research sites nearby

    Select from list below to view details:

    • John Hunter Hospital

      Newcastle, New South Wales, Australia

    • Royal North Shore Hospital

      Sydney, New South Wales, Australia

    • Westmead Hospital

      Westmead, New South Wales, Australia

    • Princess Alexandra Hospital

      Brisbane, Queensland, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    ACTIVE_COMPARATOR: Sedation, temperature device and high MAP
    • 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
    • If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
    ACTIVE_COMPARATOR: Sedation, no temperature device and high MAP
    • Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>85mmHg.
    OTHER: High MAP
    • A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.
    ACTIVE_COMPARATOR: Sedation, temperature device and low MAP
    • 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
    • If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
    ACTIVE_COMPARATOR: Sedation, no temperature device and low MAP
    • Continuous deep sedation for 36 hours. Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.
    OTHER: Deep sedation
    • Deep sedation for at least 36h
    ACTIVE_COMPARATOR: Minimal sedation, temperature device and high MAP
    • 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
    • If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
    ACTIVE_COMPARATOR: Minimal sedation, no temperature device and high MAP
    • Minimal sedation (and early extubation if possible). Fever management without a feedback-controlled device. A mean arterial pressure target of \>65mmHg.
    OTHER: High MAP
    • A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h.
    ACTIVE_COMPARATOR: Minimal sedation, temperature device and low MAP
    • 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
    • If core body temperature exceeds 37.7°C a feedback controlled-device will be used and set at 37.5°C.
    ACTIVE_COMPARATOR: Minimal sedation, no temperature device and low MAP
    • 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
    • Management of fever in the ICU without a device

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    MortalityLandmark mortality at follow-up performed at 6 months6 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Functional outcomeProportion of patients who have a mRS score of 4-66 months
    Health-related quality of lifeEQ5D-5L VAS6 months

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

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    References

    Clinical Trials Gov: Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

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