Stepcare Extended Follow-up Substudy

Last updated: April 17, 2025
Sponsor: Region Skane
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Learning Disorders

Dementia

Treatment

Low MAP

High MAP

Deep sedation

Clinical Study ID

NCT06207942
extfustep2024
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

All OHCA participants randomized in the STEPCARE trial at the extended follow-up participating sites, who survive and provide consent, with no further inclusion or exclusion criteria.

The inclusion and exclusion criteria for the STEPCARE trial are:

  • Inclusion criteria: out-of-hospital cardiac arrest of non-traumatic origin, minimumof 20 minutes without chest compressions (defined as stable return of spontaneouscirculation. ROSC), unconsciousness (defined as not being able to obey verbalcommands equal to a FOUR-score motor response of <4, or being intubated and sedatedbecause of agitation after sustained ROSC, eligible for intensive care withoutrestrictions or limitation, inclusion within 4 hours (240 minutes) of ROSC (or 220minutes of stable ROSC).

Exclusion

  • Exclusion criteria: on ECMO prior to randomization, pregnancy, suspected orconfirmed intracranial hemorrhage, previously randomized in the STEPCARE trial.

For caregivers, the eligibility will be that they live with, or have weekly or more frequent contact (in person or over the telephone) with the post OHCA survivor. Only one nominated caregiver per post OHCA survivor will be able to be included in the study. This would typically be the caregiver that would identify as the primary caregiver of the post OHCA survivor if needed, but may also be another close family member.

Study Design

Total Participants: 600
Treatment Group(s): 6
Primary Treatment: Low MAP
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
July 31, 2027

Study Description

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.

Connect with a study center

  • Princess Alexandra Hospital

    Brisbane,
    Australia

    Active - Recruiting

  • The Sutherland Hospital

    Caringbah,
    Australia

    Active - Recruiting

  • The Prince Charles Hospital

    Chermside,
    Australia

    Active - Recruiting

  • Nepean hospital

    Kingswood,
    Australia

    Active - Recruiting

  • St George hospital

    Kogarah,
    Australia

    Active - Recruiting

  • Liverpool hospital

    Liverpool,
    Australia

    Active - Recruiting

  • Austin hospital

    Melbourne,
    Australia

    Active - Recruiting

  • Royal North Shore Hospital

    Sydney,
    Australia

    Active - Recruiting

  • Ziekenhuis Oost Limburg

    Genk,
    Belgium

    Active - Recruiting

  • Ghent university hospital

    Ghent,
    Belgium

    Active - Recruiting

  • Helsinki Helsingfors university central hospital

    Helsinki,
    Finland

    Active - Recruiting

  • Jorvi hospital

    Jorvi,
    Finland

    Active - Recruiting

  • Tampere university hospital

    Tampere,
    Finland

    Active - Recruiting

  • Charite university hospital

    Berlin,
    Germany

    Active - Recruiting

  • Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein

    Lübeck,
    Germany

    Active - Recruiting

  • Tubingen university hospital

    Tubingen,
    Germany

    Active - Recruiting

  • Centre Hospitalier de Luxembourg

    Luxembourg,
    Luxembourg

    Active - Recruiting

  • Auckland city hospital

    Auckland,
    New Zealand

    Active - Recruiting

  • Middlemore hospital

    Auckland,
    New Zealand

    Active - Recruiting

  • Christchurch hospital

    Christchurch,
    New Zealand

    Active - Recruiting

  • Wellington hospital

    Wellington,
    New Zealand

    Active - Recruiting

  • Sorlandet hospital

    Arendal,
    Norway

    Active - Recruiting

  • Oslo university hospital Rikshospitalet

    Oslo,
    Norway

    Active - Recruiting

  • Sahlgrenska university hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Hallands hospital

    Halland,
    Sweden

    Active - Recruiting

  • Helsingborg hospital

    Helsingborg,
    Sweden

    Active - Recruiting

  • Skåne university hospital

    Lund,
    Sweden

    Active - Recruiting

  • Skåne university hopsital

    Malmö,
    Sweden

    Active - Recruiting

  • Bern university hospital

    Bern,
    Switzerland

    Active - Recruiting

  • Kantonsspital St. Gallen

    Saint Gallen,
    Switzerland

    Active - Recruiting

  • The Essex Cardiothoracic Centre

    Basildon,
    United Kingdom

    Active - Recruiting

  • Bristol Royal Infirmary

    Bristol,
    United Kingdom

    Active - Recruiting

  • University hospital of Wales

    Cardiff,
    United Kingdom

    Active - Recruiting

  • St Bartholomew's hospital

    London,
    United Kingdom

    Active - Recruiting

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