Status:
RECRUITING
Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Rigshospitalet, Denmark
Conditions:
Cardiac Arrest (CA)
Anoxic Brain Injury
Eligibility:
All Genders
18+ years
Brief Summary
WAKE-OHCA is a prospective observational substudy of the Danish Out-of-Hospital Cardiac Arrest (DANOHCA) trial, identifier NCT05895838. The aim is to collect early neuromonitoring data to identify key...
Detailed Description
Background: Post-resuscitation care following out-of-hospital cardiac arrest remains a critical area of research to optimize neurological recovery and cardiovascular outcomes. Recent findings from th...
Eligibility Criteria
Inclusion
- Age ≥18 years
- OHCA of presumed cardiac cause
- Sustained ROSC, defined as persistent signs of circulation and no need for chest compressions or mechanical circulatory support for 20 minutes
- Unconsciousness (GCS \<9) (patients not able to obey verbal commands) after sustained ROSC at the time of randomization
Exclusion
- Females of childbearing potential if pregnancy is suspected (unless a negative HCG test can rule out pregnancy within the inclusion window)
- Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)
- Suspected or confirmed acute intracranial bleeding
- Suspected or confirmed acute stroke
- Unwitnessed asystole
- Known limitations in therapy and Do Not Resuscitate-order
- Known disease making 180 days survival unlikely
- Known pre-arrest CPC 3 or 4 functional status
- \>3 hours (180 minutes) from ROSC to screening
- Systolic blood pressure \<80 mm Hg despite fluid loading/vasopressor and/or inotropic medication (If the systolic blood pressure is recovering during the inclusion window of 180 minutes the patient may be included)
- Use of intra-aortic balloon pump/axial flow device/ECMO (If the patient is weaned and the device is removed during the inclusion window of 180 minutes the patient may be included)
- Temperature on admission \<30°C
- Known allergy for dexamethasone or olanzapine
- Ongoing (within 48 h) treatment with olanzapine or dexamethasone
- Known back or hip condition that precluded the patients from being positioned with backrest from 0 to 45-degree angle
- Known or suspected Long QT Syndrome (LQTS)
- Known active fungal disease. Localized skin lesions do not exclude patients from inclusion
- Estimated body weight \<45kg
Key Trial Info
Start Date :
May 13 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06979700
Start Date
May 13 2025
End Date
December 1 2027
Last Update
November 18 2025
Active Locations (2)
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1
Department of Intensive Care Medicine
Aarhus N, Denmark, DK-8200
2
Department of Cardiology, The Heart Centre, Rigshospitalet
Copenhagen, Denmark, DK-2100