Actively Recruiting
Early Wake-up Predictors After Out-of-hospital Cardiac Arrest - an Observational, Multicenter Substudy of the DANOHCA Trial
Led by University of Aarhus · Updated on 2025-11-18
250
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating early predictors of wake-up success after out-of-hospital cardiac arrest in a prospective observational substudy (WAKE-OHCA) of the larger DANOHCA trial. This study focuses on understanding how different neuromonitoring techniques relate to patient outcomes and sedation length in post-resuscitation care. The goal is to identify key patient and neurological factors that influence early and late wake-up, improving decision-making and care strategies for unconscious patients after cardiac arrest. Participants undergo various neuromonitoring tests including automated pupillometry, transcranial doppler ultrasound, optic nerve sheath diameter ultrasound, and continuous EEG with reactivity testing. These measurements are taken at multiple time points from enrollment up to 72 hours in comatose patients to assess neurological status and cerebral blood flow. The study collects data on sedation length, patient variables, and outcomes to analyze predictors of wake-up success and neurological recovery. During the study, researchers collect baseline medical and cardiac arrest data from medical records and registries. Neuromonitoring data is gathered repeatedly within the first 72 hours after enrollment. The primary outcome is the number of patients who successfully wake up early or later according to sedation protocols. Secondary outcomes include mortality, length of ICU and hospital stay, days alive outside the hospital, and neurological function up to six months. Participant safety is monitored throughout, and treatments remain standard care without influence from neuromonitoring results.
CONDITIONS
Brief Title
Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Out-of-hospital cardiac arrest of presumed cardiac cause
- Sustained return of spontaneous circulation for more than 20 minutes
- Unconsciousness with Glasgow Coma Scale less than 9 after return of spontaneous circulation at time of randomization
You will not qualify if you...
- Females of childbearing potential if pregnancy is suspected unless a negative pregnancy test is confirmed
- Known bleeding disorders (except medically induced coagulopathy)
- Suspected or confirmed acute intracranial bleeding or stroke
- Unwitnessed asystole
- Known therapy limitations or Do Not Resuscitate orders
- Known disease limiting survival to less than 180 days
- Pre-arrest cerebral performance category of 3 or 4
- More than 3 hours from return of spontaneous circulation to screening
- Systolic blood pressure below 80 mm Hg despite treatment (unless recovering during inclusion window)
- Use of intra-aortic balloon pump, axial flow device, or ECMO unless removed during inclusion window
- Body temperature on admission below 30 degrees Celsius
- Known allergy or ongoing treatment with dexamethasone or olanzapine
- Known back or hip conditions preventing positioning with backrest 0 to 45 degrees
- Known or suspected Long QT Syndrome
- Known active fungal disease except localized skin lesions
- Estimated body weight less than 45 kilograms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 hours from return of spontaneous circulation to screening
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 hours after enrolment with assessments at 0-6, 20-28, 44-52, and 66-72 hours
Neuromonitoring measurements including automated pupillometry, transcranial doppler ultrasound, optic nerve sheath diameter ultrasound, and continuous EEG with EEG reactivity tests are performed on comatose participants to assess neurological status and recovery patterns after out-of-hospital cardiac arrest.
4 measurement sessions within 72 hours
Duration - Up to 6 months
Participants are observed for outcomes including wake-up success, duration of intubation, mortality, length of ICU and hospital stay, and neurological performance up to 6 months after enrolment.
Follow-up visits as part of routine care up to 6 months
Trial Site Locations
Total: 2 locations
1
Department of Intensive Care Medicine
Aarhus N, Denmark, DK-8200
Actively Recruiting
2
Department of Cardiology, The Heart Centre, Rigshospitalet
Copenhagen, Denmark, DK-2100
Actively Recruiting
Research Team
C
Christopher Torp Lohse, MD
A
Anders Grejs, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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