Cardiac Arrest With Successful Resuscitation, Caregiver Burden, Cognitive Impairment, Hypoxia, Brain
Conditions
Brief 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.
Detailed description
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.
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
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
Sponsors
Lund University
The George Institute for Global Health, Australia
Copenhagen Trial Unit, Center for Clinical Intervention Research
Helsinki University Central Hospital
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
2X2X2 factorial., with all participants taking part in each factor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | 6 months | Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition |
| Zarit Burden Interview (ZBI) | 6 months | Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post Posttraumatic Stress Disorders Checklist updated for DSM-5 (PCL-5) | 6 and 12 months | 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 |
| Modified Fatigue Impact Scale (MFIS) | 6 and 12 months | Impact of fatigue. For out of hospital cardiac arrest survivors. Score range 0-84. Higher scores= worse indicating more problems with impact of fatigue |
| modified Rankin Scale (mRS) | 12 months | Functional outcome. For out of hospital cardiac arrest survivors. Score range 0-6. Higher scores= worse indicating a poorer functional outcome |
| World Health Organization Disability Assessment (WHODAS) 2.0 | 6 and 12 months | 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 |
| Symbol Digit Modalities Test (SDMT) | 6 and 12 months | Processing speed. For out of hospital cardiac arrest survivors. Scores presented as age and education adjusted z-scores. Higher scores=better |
| EuroQol health survey 5 dimensions 5 levels response version (EQ-5D-5L) | 12 months for out of hospital cardiac arrest survivors. 6 and 12 months for caregiver | 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 |
| Life satisfaction visual analogue scale from the World Value Survey | 6 and 12 months | Life satisfaction. For both out of hospital cardiac arrest survivors and caregivers. Score range 1-10. Higher scores=better indicating better life satisfaction |
| Timed Stands Test (TST) | 6 and 12 months | Lower extremity strength. For out of hospital cardiac arrest survivors. Raw score adjusted for gender and age and categorized as normal, problems or unable. |
| Jamar hand grip dynamometer | 6 and 12 months | Upper extremity strength. For out of hospital cardiac arrest survivors. Raw scores age and gender adjusted and categorized as normal, problems or unable. |
| Return to work | 6 and 12 months | 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 |
| Hospital Anxiety and Depression Scale (HADS) | 6 and 12 months | 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 |
Countries
Australia, Belgium, Finland, Germany, Luxembourg, New Zealand, Norway, Sweden, Switzerland, United Kingdom
Contacts
Primary ContactGisela Lilja, PhD
Outcome results
None listed