RecruitingNCT06979700

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

Early Wake-up Predictors After Out-of-hospital Cardiac Arrest - an Observational, Multicenter Substudy of the DANOHCA Trial

Sponsor

University of Aarhus

Enrollment

250 participants

Start Date

May 13, 2025

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria18

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

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Interventions

DIAGNOSTIC_TESTAutomated Pupillometry

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.

DIAGNOSTIC_TESTTranscranial Doppler Ultrasound

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.

DIAGNOSTIC_TESTOptic Nerve Sheath Diameter

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.

DIAGNOSTIC_TESTContinuous EEG and EEG Reactivity

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.