NCT05895838 The Danish Out-of-Hospital Cardiac Arrest Study
| NCT ID | NCT05895838 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Christian Hassager |
| Condition | Out-Of-Hospital Cardiac Arrest |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-06-16 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,000 participants in total. It began in 2023-06-16 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
After resuscitation from Out-of-Hospital Cardiac Arrest (OHCA) patients experience Post Cardiac Arrest Syndrome due to ischemia and reperfusion injury. It consists of systemic inflammation, cerebral and myocardial dysfunction, and the condition that led to the arrest. Most OHCA patients will receive critical care intubated in an Intensive Care Unit (ICU). Despite this \~50% die; mainly due to brain injury. Several targets can be considered for improving outcomes. To dampen systemic inflammation and optimize cerebral perfusion seem important. Deep sedation has been required for targeted temperature management (TTM) but may also be brain protective. After end of sedation, many patients have some cerebral dysfunction that may facilitate delirium. The aim of this trial is therefore to improve treatment of comatose OHCA patients by evaluating 4 interventions in a factorial design addressing each of these targets in a randomized clinical trial: 1. Systemic inflammation: Anti-inflammatory treatment with high dose steroids (dexamethasone) or placebo. 2. Cerebral perfusion: Backrest elevation during sedation at 5 or 35 degrees. 3. Duration of sedation: Early wakeup call and potential extubation at ≤6 hours after admission or later as current standard practice at 28-36 hours. 4. Delirium: Prophylactic treatment with anti-psychotic medication (olanzapine) or placebo. The trial is designed as a phase III trial, randomizing 1000 patients at Danish cardiac arrest centers. The primary endpoint is 90 days all-cause mortality for the interventions targeting systemic inflammation and cerebral perfusion, while it is days alive outside of hospital within 30 days for the interventions concerning duration of sedation and delirium. The trial has potential to improve outcomes for comatose OHCA patients - a group with a grave prognosis with currently only limited evidence-based treatments.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years 2. OHCA of presumed cardiac cause 3. Sustained ROSC, defined as persistent signs of circulation and no need for chest compressions or mechanical circulatory support for 20 minutes 4. Unconsciousness (GCS \<9) (patients not able to obey verbal commands) after sustained ROSC at the time of randomization Exclusion Criteria: 1. Females of childbearing potential if pregnancy is suspected (unless a negative HCG test can rule out pregnancy within the inclusion window) 2. Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient) 3. Suspected or confirmed acute intracranial bleeding 4. Suspected or confirmed acute stroke 5. Unwitnessed asystole 6. Known limitations in therapy and Do Not Resuscitate-order 7. Known disease making 180 days survival unlikely 8. Known pre-arrest CPC 3 or 4 functional status 9. \>3 hours (180 minutes) from ROSC to screening 10. 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) 11. 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) 12. Temperature on admission \<30°C 13. Known allergy for dexamethasone or olanzapine 14. Ongoing (within 48 h) treatment with olanzapine or dexamethasone 15. Known back or hip condition that precluded the patients from being positioned with backrest from 0 to 45-degree angle 16. Known or suspected Long QT Syndrome (LQTS) 17. Known active fungal disease. Localized skin lesions do not exclude patients from inclusion 18. Estimated body weight \<45kg
Contact & Investigator
Christian Hassager, MD DMSc
STUDY CHAIR
Dept. of Cardiology, Rigshospitalet
Frequently Asked Questions
Who can join the NCT05895838 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Out-Of-Hospital Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05895838 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,000 participants.
Is NCT05895838 currently recruiting?
Yes, NCT05895838 is actively recruiting participants. Contact the research team at christian.hassager@regionh.dk for enrollment information.
Where is the NCT05895838 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Aalborg, Denmark, Aarhus, Denmark, Køge, Denmark and 1 additional location.
Who is sponsoring the NCT05895838 clinical trial?
NCT05895838 is sponsored by Christian Hassager. The principal investigator is Christian Hassager, MD DMSc at Dept. of Cardiology, Rigshospitalet. The trial plans to enroll 1,000 participants.