Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06207942

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

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

Follow-up

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

Actively Recruiting

3

The Prince Charles Hospital

Chermside, Australia

Actively Recruiting

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

Actively Recruiting

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

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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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