RecruitingNot ApplicableNCT06207942

Stepcare Extended Follow-up Substudy

Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial


Sponsor

Region Skane

Enrollment

600 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Exclusion Criteria1

  • 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.

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Interventions

DEVICEFeed 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

OTHERHigh MAP

A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours

OTHERDeep sedation

Deep sedation for at least 36 hours

OTHERFever control without a device

Management of fever in the intensive care unit without a device

OTHERLow MAP

A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours

OTHERMinimal sedation

A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures


Locations(34)

Princess Alexandra Hospital

Brisbane, Australia

The Sutherland Hospital

Caringbah, Australia

The Prince Charles Hospital

Chermside, Australia

Nepean hospital

Kingswood, Australia

St George hospital

Kogarah, Australia

Liverpool hospital

Liverpool, Australia

Austin hospital

Melbourne, Australia

Royal North Shore Hospital

Sydney, Australia

Ziekenhuis Oost Limburg

Genk, Belgium

Ghent university hospital

Ghent, Belgium

Helsinki Helsingfors university central hospital

Helsinki, Finland

Jorvi hospital

Jorvi, Finland

Tampere university hospital

Tampere, Finland

Charite university hospital

Berlin, Germany

Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Tubingen university hospital

Tübingen, Germany

Centre Hospitalier de Luxembourg

Luxembourg, Luxembourg

Auckland city hospital

Auckland, New Zealand

Middlemore hospital

Auckland, New Zealand

Christchurch hospital

Christchurch, New Zealand

Wellington hospital

Wellington, New Zealand

Sorlandet hospital

Arendal, Norway

Oslo university hospital Rikshospitalet

Oslo, Norway

Sahlgrenska university hospital

Gothenburg, Sweden

Hallands hospital

Hålland, Sweden

Helsingborg hospital

Helsingborg, Sweden

Skåne university hospital

Lund, Sweden

Skåne university hopsital

Malmo, Sweden

Bern university hospital

Bern, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

The Essex Cardiothoracic Centre

Basildon, United Kingdom

Bristol Royal Infirmary

Bristol, United Kingdom

University hospital of Wales

Cardiff, United Kingdom

St Bartholomew's hospital

London, United Kingdom

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NCT06207942


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