Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest (NCT06979700) | Clinical Trial Compass
RecruitingNot Applicable
Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest
Denmark250 participantsStarted 2025-05-13
Plain-language 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 predictors of successful wake-up.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
* Know…
What they're measuring
1
Number of patients with successful wake-up
Timeframe: 0-6 hours or 28-36 hours according to DANOHCA randomization.