Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest
WAKE-OHCA
Early Wake-up Predictors After Out-of-hospital Cardiac Arrest - an Observational, Multicenter Substudy of the DANOHCA Trial
2 other identifiers
observational
250
1 country
2
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 predictors of successful wake-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2025
CompletedStudy Start
First participant enrolled
May 13, 2025
CompletedFirst Posted
Study publicly available on registry
May 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
November 18, 2025
May 1, 2025
2.3 years
May 13, 2025
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with successful wake-up
Defined as awake and successfully extubated.
0-6 hours or 28-36 hours according to DANOHCA randomization.
Secondary Outcomes (8)
Number of patients with successful delayed wake-up
Up to 90 days.
Duration of intubation
Up to 90 days.
Days alive outside hospital
30 days.
30-day mortality
30 days.
90-day mortality
90 days.
- +3 more secondary outcomes
Interventions
Measurements will be performed on comatose participants at 0-6 hours, 20-28, 44-52 and 66-72 hours after enrolment for both pupils and include: Neurological pupil index, pupillary size, pupillary minimum diameter, pupillary constriction amplitude, pupillary constriction velocity, pupillary maximum constriction velocity, pupillary latency and pupillary dilation velocity.
Measurements will be performed on comatose participants at 0-6 hours, 20-28, 44-52 and 66-72 hours after enrolment on both middle cerebral arteries and include the following: Peak systolic velocity, end diastolic velocity, mean velocity, pulsatility index and resistance index.
Measurements will be performed on comatose participants at 0-6 hours, 20-28, 44-52 and 66-72 hours after enrolment on both eyes using ultrasound and include the following: optic nerve sheath diameter of right and left side and mean optic nerve sheath diameter.
Continuous 4-channel EEG will be established on participants as soon as possible within 0-6 hours. EEG will be stopped at successful extubation or when 72 hours has passed since study inclusion. EEG Reactivity will be performed on comatose participants at the following times: 0-6, 20-28, 44-52 and 66-72 hours after study inclusion. Reactivity includes 7 standardized stimuli, including 1 visual, 3 auditive and 3 pain stimuli. EEG data will be reviewed in Stratus EEG Analysis (Kvikna Mediacal ehf. version 5.1). Timestamps for EEG-reactivity will be manually inserted in the file. EEG Reactivity will be analysed quantitatively by power spectrum analyses performed in LabVIEW 2016 (National Instruments) according to the principles of a previous method (PMID: 36041343). Background activity within 5 minutes following reactivity stimuli, prioritizing time periods without artifacts, will be analysed by power spectrum analyses, Mindray quantitative analysis and manually analyzed by experts.
Eligibility Criteria
Patients enrolled in the DANOHCA trial at Aarhus University Hospital and Rigshospitalet.
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:
- 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
- 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)
- Estimated body weight \<45kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Rigshospitalet, Denmarkcollaborator
Study Sites (2)
Department of Intensive Care Medicine
Aarhus N, DK-8200, Denmark
Department of Cardiology, The Heart Centre, Rigshospitalet
Copenhagen, DK-2100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian Hassager, MD, DMSc
Department of Cardiology, Rigshospitalet
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2025
First Posted
May 20, 2025
Study Start
May 13, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
November 18, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share