Identifying predictors for waking up after cardiac arrest
Early Wake-up Predictors After Out-of-hospital Cardiac Arrest - an Observational, Multicenter Substudy of the DANOHCA Trial
This study is trying to find out which early signs can help doctors predict if patients will wake up successfully after having a cardiac arrest outside the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus N and 1 other locations) |
| Trial ID | NCT06979700 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather early neuromonitoring data from patients who have experienced out-of-hospital cardiac arrest to identify key predictors of successful wake-up. It is a substudy of the larger DANOHCA trial, focusing on the implications of sedation strategies in post-resuscitation care. The study will utilize various neuromonitoring techniques, including automated pupillometry, transcranial doppler ultrasound, and continuous EEG, to assess their prognostic value within the first six hours after resuscitation. The goal is to enhance clinical decision-making regarding sedation and improve neurological recovery outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an out-of-hospital cardiac arrest of presumed cardiac cause and are unconscious after sustained return of spontaneous circulation.
Not a fit: Patients with known bleeding disorders, acute intracranial bleeding, or those who are unlikely to survive 180 days are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for waking patients from sedation after cardiac arrest, potentially enhancing neurological recovery.
How similar studies have performed: While there is emerging interest in early weaning from sedation, limited data exist on its feasibility and prognostic implications, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 this trial is running
Aarhus N and 1 other locations
- Department of Intensive Care Medicine — Aarhus N, Denmark (Recruiting)
- Department of Cardiology, The Heart Centre, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Christopher Torp Lohse, MD
- Email: chtorp@rm.dk
- Phone: +4526745886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.