An interventional study of Feed back controlled temperature device and High MAP in Cardiac Arrest With Successful Resuscitation, Hypoxia, Brain and Cognitive Impairment, sponsored by Region Skane. Recruiting at 34 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
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.
81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.
This study's planned enrollment of 600 is above the median of 60 across 55 interventional studies indexed under Hypoxia, Brain.
Browse Hypoxia, Brain studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Device: Feed back controlled temperature device · Other: High MAP · Other: Deep sedation
Other: High MAP · Other: Deep sedation · Other: Fever control without a device
Device: Feed back controlled temperature device · Other: Deep sedation · Other: Low MAP
Other: Deep sedation · Other: Fever control without a device · Other: Low MAP
Device: Feed back controlled temperature device · Other: High MAP · Other: Minimal sedation
Other: High MAP · Other: Fever control without a device · Other: Minimal sedation
Device: Feed back controlled temperature device · Other: Low MAP · Other: Minimal sedation
Other: Fever control without a device · Other: Low MAP · Other: Minimal sedation
If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
Deep sedation for at least 36 hours
Management of fever in the intensive care unit without a device
A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Montreal Cognitive Assessment (MoCA)
Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition
Time frame: 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
Time frame: 6 months
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
Time frame: 6 and 12 months
Hospital Anxiety and Depression Scale (HADS)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6 and 12 months
Plan to share: Undecided — Upon resonable request following publication
Started Aug 2023 (actual). Primary completion is estimated for Jan 2027, 41 months after the start.
Of 33 non-industry interventional studies with no phase under Hypoxia, Brain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 44. This study's planned 41 months is above that.
Counting every sponsor, half of 33 studies reached it within 20 months; a quarter within 7 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.