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Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation STEPCARE Trial
Led by Region Skane · Updated on 2025-04-23
600
Participants Needed
34
Research Sites
30 weeks
Total Duration
On this page
Sponsors
R
Region Skane
Lead Sponsor
L
Lund University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating long-term outcomes in survivors of out-of-hospital cardiac arrest, focusing on how different targets for sedation, temperature, and blood pressure management affect brain protection and recovery. This study is part of a larger international, multi-center randomized trial called STEPCARE. The study also explores the impact of caregiving on those caring for cardiac arrest survivors. Participants in the STEPCARE trial are randomly assigned to various combinations of sedation levels (deep or minimal), temperature management (using a feedback-controlled device or fever control without a device), and blood pressure targets (high MAP above 85 mmHg or low MAP above 65 mmHg). These interventions are applied during the initial treatment period. The extended follow-up substudy enrolls survivors from selected sites who consent, following them and their nominated caregivers at 6 and 12 months after cardiac arrest. During the follow-up, researchers assess cognitive function of survivors using the Montreal Cognitive Assessment (MoCA) and measure caregiver burden with the Zarit Burden Interview (ZBI) at 6 months. The study includes questionnaires and evaluations to understand recovery and caregiving challenges. Participants are monitored over a total of 12 months, with data collected at both 6 and 12 months to evaluate long-term effects of the initial treatments and caregiving experiences.
CONDITIONS
Brief Title
Stepcare Extended Follow-up Substudy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Out-of-hospital cardiac arrest of non-traumatic origin
- At least 20 minutes without chest compressions with stable return of spontaneous circulation (ROSC)
- Unconsciousness after cardiac arrest, defined as inability to obey verbal commands or requiring sedation
- Eligible for intensive care without restrictions
- Included within 4 hours (240 minutes) of ROSC or 220 minutes of stable ROSC
- Survived the initial STEPCARE trial and provide consent for this substudy
- Caregivers live with or have weekly or more frequent contact with the survivor
You will not qualify if you...
- Being on extracorporeal membrane oxygenation (ECMO) prior to randomization
- Pregnancy
- Suspected or confirmed intracranial hemorrhage
- Previously randomized in the STEPCARE trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 36 hours
Participants receive randomized strategies of sedation, temperature, and blood pressure management in the intensive care unit following cardiac arrest.
Continuous monitoring during the treatment period
Duration - Up to 12 months
Participants are followed up to assess cognitive function and caregiver burden after treatment.
2 visits at 6 months and 12 months
Trial Site Locations
Total: 34 locations
1
Princess Alexandra Hospital
Brisbane, Australia
Actively Recruiting
2
The Sutherland Hospital
Caringbah, Australia
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3
The Prince Charles Hospital
Chermside, Australia
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4
Nepean hospital
Kingswood, Australia
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5
St George hospital
Kogarah, Australia
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6
Liverpool hospital
Liverpool, Australia
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7
Austin hospital
Melbourne, Australia
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8
Royal North Shore Hospital
Sydney, Australia
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9
Ziekenhuis Oost Limburg
Genk, Belgium
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10
Ghent university hospital
Ghent, Belgium
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11
Helsinki Helsingfors university central hospital
Helsinki, Finland
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12
Jorvi hospital
Jorvi, Finland
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13
Tampere university hospital
Tampere, Finland
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14
Charite university hospital
Berlin, Germany
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15
Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
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16
Tubingen university hospital
Tübingen, Germany
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17
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg
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18
Auckland city hospital
Auckland, New Zealand
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19
Middlemore hospital
Auckland, New Zealand
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20
Christchurch hospital
Christchurch, New Zealand
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21
Wellington hospital
Wellington, New Zealand
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22
Sorlandet hospital
Arendal, Norway
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23
Oslo university hospital Rikshospitalet
Oslo, Norway
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24
Sahlgrenska university hospital
Gothenburg, Sweden
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25
Hallands hospital
Hålland, Sweden
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26
Helsingborg hospital
Helsingborg, Sweden
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27
Skåne university hospital
Lund, Sweden
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28
Skåne university hopsital
Malmö, Sweden
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29
Bern university hospital
Bern, Switzerland
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30
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
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31
The Essex Cardiothoracic Centre
Basildon, United Kingdom
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32
Bristol Royal Infirmary
Bristol, United Kingdom
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33
University hospital of Wales
Cardiff, United Kingdom
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34
St Bartholomew's hospital
London, United Kingdom
Actively Recruiting
Research Team
G
Gisela Lilja, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
8
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