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Clinical Trials in Australia / NCT06207942
Recruiting Not applicable

Stepcare Extended Follow-up Substudy

NCT06207942 · tracked via the Priya Life Science Australia tracker
Sponsor
Region Skane
Phase
Not applicable
Started
2023-08-01
Last updated
2025-04-23

Condition(s) studied

Cardiac Arrest With Successful ResuscitationHypoxia, BrainCognitive ImpairmentCaregiver Burden

Investigational drug(s) / intervention(s)

Feed back controlled temperature deviceHigh MAPDeep sedationFever control without a deviceLow MAPMinimal sedation

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

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

Deep sedation: Deep sedation for at least 36 hours

Fever control without a device: Management of fever in the intensive care unit without a device

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

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, 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. 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.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Princess Alexandra Hospital Brisbane Australia Recruiting
The Sutherland Hospital Caringbah Australia Recruiting
The Prince Charles Hospital Chermside Australia Recruiting
Nepean hospital Kingswood Australia Recruiting
St George hospital Kogarah Australia Recruiting
Liverpool hospital Liverpool Australia Recruiting
Austin hospital Melbourne Australia Recruiting
Royal North Shore Hospital Sydney Australia Recruiting
Ziekenhuis Oost Limburg Genk Belgium Recruiting
Ghent university hospital Ghent Belgium Recruiting
Helsinki Helsingfors university central hospital Helsinki Finland Recruiting
Jorvi hospital Jorvi Finland Recruiting
Tampere university hospital Tampere Finland Recruiting
Charite university hospital Berlin Germany Recruiting
Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein Lübeck Germany Recruiting
Tubingen university hospital Tübingen Germany Recruiting
Centre Hospitalier de Luxembourg Luxembourg Luxembourg Recruiting
Auckland city hospital Auckland New Zealand Recruiting
Middlemore hospital Auckland New Zealand Recruiting
Christchurch hospital Christchurch New Zealand Recruiting
Wellington hospital Wellington New Zealand Recruiting
Sorlandet hospital Arendal Norway Recruiting
Oslo university hospital Rikshospitalet Oslo Norway Recruiting
Sahlgrenska university hospital Gothenburg Sweden Recruiting
Hallands hospital Hålland Sweden Recruiting
Helsingborg hospital Helsingborg Sweden Recruiting
Skåne university hospital Lund Sweden Recruiting
Skåne university hopsital Malmö Sweden Recruiting
Bern university hospital Bern Switzerland Recruiting
Kantonsspital St. Gallen Sankt Gallen Switzerland Recruiting
The Essex Cardiothoracic Centre Basildon United Kingdom Recruiting
Bristol Royal Infirmary Bristol United Kingdom Recruiting
University hospital of Wales Cardiff United Kingdom Recruiting
St Bartholomew's hospital London United Kingdom Recruiting

More Region Skane trials in Australia

International Care Bundle Evaluation in Cerebral Hemorrhage Research Recruiting
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation Active, not recruiting

Other trials for the same condition

Technology Assisted Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment Active, not recruiting
Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour Recruiting
The Effect of OSA on Brain Waste Clearance Enrolling by invitation
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06207942 on ClinicalTrials.gov ↗ ← All trials in Australia