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| Name | Class |
|---|---|
| Lund University | OTHER |
| The George Institute for Global Health, Australia | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation, temperature device and high MAP | Active Comparator |
| |
| Sedation, no temperature device and high MAP | Active Comparator |
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| Sedation, temperature device and low MAP | Active Comparator |
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| Sedation, no temperature device, and low MAP | Active Comparator |
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| Minimal sedation, temperature device, and high MAP | Active Comparator |
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| Minimal sedation, no temperature device and high MAP | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feed back controlled temperature device | Device | If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition | 6 months |
| Zarit Burden Interview (ZBI) | Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden | 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Symbol Digit Modalities Test (SDMT) | Processing speed. For out of hospital cardiac arrest survivors. Scores presented as age and education adjusted z-scores. Higher scores=better | 6 and 12 months |
| Hospital Anxiety and Depression Scale (HADS) |
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:
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gisela Lilja, PhD | Contact | +4646176393 | gisela.lilja@med.lu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Alexandra Hospital | Recruiting | Brisbane | Australia |
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| Label | URL |
|---|---|
| Official STEPCARE trial website | View source |
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Upon resonable request following publication
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| Helsinki University Central Hospital |
| OTHER |
2X2X2 factorial., with all participants taking part in each factor
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Participants (out of hospital cardiac arrest survivors and caregivers) will be blinded. Assessors of neurological prognosis will be blinded. Outcome assessors and investigators will be blinded.
| Minimal sedation, temperature device and low MAP | Active Comparator |
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| Minimal sedation, no temperature device and low MAP | Active Comparator |
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| High MAP | Other | A mean arterial blood pressure (MAP) of >85mmHg will be used. Vasopressors will be titrated to this target during 36 hours |
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| Deep sedation | Other | Deep sedation for at least 36 hours |
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| Fever control without a device | Other | Management of fever in the intensive care unit without a device |
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| Low MAP | Other | A mean arterial blood pressure (MAP) of >65mmHG will be used. Vasopressors will be titrated to this target during 36 hours |
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| Minimal sedation | Other | A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures |
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Symptoms of anxiety and depression. For both out of hospital cardiac arrest survivors and caregivers. Score range 0-21 for anxiety and depression respectively. Higher scores=worse and incerased symptoms of anxiety and depression
| 6 and 12 months |
| Post Posttraumatic Stress Disorders Checklist updated for DSM-5 (PCL-5) | Symptoms of posttraumatic stress. For both out of hospital cardiac arrest survivors and caregivers. Score range 0-80. Higher scores=worse indicating increased symptoms of PTSD | 6 and 12 months |
| Modified Fatigue Impact Scale (MFIS) | Impact of fatigue. For out of hospital cardiac arrest survivors. Score range 0-84. Higher scores= worse indicating more problems with impact of fatigue | 6 and 12 months |
| modified Rankin Scale (mRS) | Functional outcome. For out of hospital cardiac arrest survivors. Score range 0-6. Higher scores= worse indicating a poorer functional outcome | 12 months |
| World Health Organization Disability Assessment (WHODAS) 2.0 | Disability. For both out of hospital cardiac arrest survivors and caregivers. 36 item version score range 0-100. 12 item version score range 0-48. Higher scores=worse indicating more disability | 6 and 12 months |
| Return to work | Questions about work prior to cardiac arrest and at time of follow up. For both out of hospital cardiac arrest survivors and caregivers. Categorical item | 6 and 12 months |
| EuroQol health survey 5 dimensions 5 levels response version (EQ-5D-5L) | Health related quality of life. For both out of hospital cardiac arrest survivors and caregivers. For EQ dimensions score range 1-5 and higher scores=worse indicating more health problems. For EQ VAS score range is 0-100 with higher scores= better and representing higher satisfaction with overall health | 12 months for out of hospital cardiac arrest survivors. 6 and 12 months for caregiver |
| Life satisfaction visual analogue scale from the World Value Survey | Life satisfaction. For both out of hospital cardiac arrest survivors and caregivers. Score range 1-10. Higher scores=better indicating better life satisfaction | 6 and 12 months |
| Timed Stands Test (TST) | Lower extremity strength. For out of hospital cardiac arrest survivors. Raw score adjusted for gender and age and categorized as normal, problems or unable. | 6 and 12 months |
| Jamar hand grip dynamometer | Upper extremity strength. For out of hospital cardiac arrest survivors. Raw scores age and gender adjusted and categorized as normal, problems or unable. | 6 and 12 months |
| The Sutherland Hospital | Recruiting | Caringbah | Australia |
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| The Prince Charles Hospital | Recruiting | Chermside | Australia |
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| Nepean hospital | Recruiting | Kingswood | Australia |
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| St George hospital | Recruiting | Kogarah | Australia |
| Liverpool hospital | Recruiting | Liverpool | Australia |
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| Austin hospital | Recruiting | Melbourne | Australia |
| Royal North Shore Hospital | Recruiting | Sydney | Australia |
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| Ziekenhuis Oost Limburg | Recruiting | Genk | Belgium |
| Ghent university hospital | Recruiting | Ghent | Belgium |
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| Helsinki Helsingfors university central hospital | Recruiting | Helsinki | Finland |
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| Jorvi hospital | Recruiting | Jorvi | Finland |
| Tampere university hospital | Recruiting | Tampere | Finland |
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| Charite university hospital | Recruiting | Berlin | Germany |
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| Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein | Recruiting | Lübeck | Germany |
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| Tubingen university hospital | Recruiting | Tübingen | Germany |
| Centre Hospitalier de Luxembourg | Recruiting | Luxembourg | Luxembourg |
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| Auckland city hospital | Recruiting | Auckland | New Zealand |
| Middlemore hospital | Recruiting | Auckland | New Zealand |
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| Christchurch hospital | Recruiting | Christchurch | New Zealand |
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| Wellington hospital | Recruiting | Wellington | New Zealand |
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| Sorlandet hospital | Recruiting | Arendal | Norway |
| Oslo university hospital Rikshospitalet | Recruiting | Oslo | Norway |
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| Sahlgrenska university hospital | Recruiting | Gothenburg | Sweden |
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| Hallands hospital | Recruiting | Hålland | Sweden |
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| Helsingborg hospital | Recruiting | Helsingborg | Sweden |
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| Skåne university hospital | Recruiting | Lund | Sweden |
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| Skåne university hopsital | Recruiting | Malmö | Sweden |
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| Bern university hospital | Recruiting | Bern | Switzerland |
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| Kantonsspital St. Gallen | Recruiting | Sankt Gallen | Switzerland |
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| The Essex Cardiothoracic Centre | Recruiting | Basildon | United Kingdom |
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| Bristol Royal Infirmary | Recruiting | Bristol | United Kingdom |
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| University hospital of Wales | Recruiting | Cardiff | United Kingdom |
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| St Bartholomew's hospital | Recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D002534 | Hypoxia, Brain |
| D060825 | Cognitive Dysfunction |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D054810 | Deep Sedation |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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