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Stepcare Extended Follow-up Substudy

RECRUITING

To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.

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Study details:

This extended follow-up substudy is incorporated into the multi-center, international, factorial randomized Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation -STEPCARE trial (Clinical trials identifier:NCT05564754) were out of hospital cardiac arrest participants will be randomized to different targets of sedation, temperature, and MAP management. Only selected STEPCARE sites will participate in this extended follow-up substudy. At the extended follow up participating sites all out of hospital cardiac arrest participants randomized in the STEPCARE trial, who survive and provide consent, will be eligible to participate in this substudy, with no further inclusion or exclusion criteria.

The extended follow-up substudy is estimated to enroll approximately 600 post OHCA survivors. One nominated caregiver per post OHCA survivor will be invited to be included in the study. Participants will be followed up at 6 and 12 months.

The primary outcome for this extended follow up substudy is cognitive function at 6 months for the out of hospital cardiac arrest survivors andCaregiver burden at 6 months for the caregivers.

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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 of non-traumatic origin
  • minimum of 20 minutes without chest compressions (defined as stable return of spontaneous circulation. ROSC)
  • unconsciousness (defined as not being able to obey verbal commands equal to a FOUR-score motor response of <4, or being intubated and sedated because of agitation after sustained ROSC)
  • eligible for intensive care without restrictions or limitation
  • inclusion within 4 hours (240 minutes) of ROSC (or 220 minutes of stable 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: 2023-08-01

    Primary completion: 2026-06-30

    Study completion finish: 2026-12-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT06207942

    Intervention or treatment

    DEVICE: Feed back controlled temperature device

    OTHER: High MAP

    OTHER: Deep sedation

    OTHER: Fever control without a device

    OTHER: Low MAP

    OTHER: Minimal sedation

    Conditions

    • Cognitive Impairment
    • Cardiac Arrest With Successful Resuscitation
    • Hypoxia, Brain
    • Caregiver Burden
    Image related to Cognitive Impairment
    • Condition: Cognitive Impairment, Cardiac Arrest With Successful Resuscitation and more

    • DEVICE: Feed back controlled temperature device and other drugs

    • Brisbane, Not Specified, Australia and more

    • Sponsor: Region Skane

    Find a site

    Closest Location:

    Princess Alexandra Hospital

    Research sites nearby

    Select from list below to view details:

    • Princess Alexandra Hospital

      Brisbane, Not Specified, Australia

    • The Prince Charles Hospital

      Chermside, Not Specified, Australia

    • The Sutherland Hospital

      Caringbah, Not Specified, Australia

    • Nepean hospital

      Kingswood, Not Specified, 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
    • Not Specified
    DEVICE: Feed back controlled temperature device
    • If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
    ACTIVE_COMPARATOR: Sedation, no temperature device and high MAP
    • Not Specified
    OTHER: High MAP
    • A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
    ACTIVE_COMPARATOR: Sedation, temperature device and low MAP
    • Not Specified
    DEVICE: Feed back controlled temperature device
    • If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
    ACTIVE_COMPARATOR: Sedation, no temperature device, and low MAP
    • Not Specified
    OTHER: Deep sedation
    • Deep sedation for at least 36 hours
    ACTIVE_COMPARATOR: Minimal sedation, temperature device, and high MAP
    • Not Specified
    DEVICE: Feed back controlled temperature device
    • If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
    ACTIVE_COMPARATOR: Minimal sedation, no temperature device and high MAP
    • Not Specified
    OTHER: High MAP
    • A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
    ACTIVE_COMPARATOR: Minimal sedation, temperature device and low MAP
    • Not Specified
    DEVICE: Feed back controlled temperature device
    • If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
    ACTIVE_COMPARATOR: Minimal sedation, no temperature device and low MAP
    • Not Specified
    OTHER: Fever control without a device
    • Management of fever in the intensive care unit without a device

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Montreal Cognitive Assessment (MoCA)Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition6 months
    Zarit Burden Interview (ZBI)Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden6 months

    Secondary outcome

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    References

    Clinical Trials Gov: Stepcare Extended Follow-up Substudy

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