Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest

Recruiting now

Conditions studied: Cardiac Arrest (CA), Anoxic Brain Injury, Comatose Survivors of Cardiac Arrest, EEG, Pupillometry, Optic Nerve Sheath Diameter, Transcranial Doppler Ultrasound, Neurological Outcome

In brief

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.

Key facts

Study ID

NCT06979700

Run by

University of Aarhus

People needed

250

Starts

2025-05-13

Expected to finish

2027-12-01

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Intensive Care Medicine — Aarhus N, Denmark (enrolling)
• Department of Cardiology, The Heart Centre, Rigshospitalet — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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