Improving outcomes for patients after out-of-hospital cardiac arrest

The Danish Out-of-Hospital Cardiac Arrest Study - a Randomized, Placebo-controlled, Double-blind, Multi Center Trial

This study is testing different treatments to see if they can help unconscious patients recover better after surviving a cardiac arrest outside of the hospital.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Locations: 5 sites (Copenhagen, Capital Region of Denmark and 4 other locations)
• Trial ID: NCT05895838 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to enhance the treatment of comatose patients who have experienced an out-of-hospital cardiac arrest (OHCA) by evaluating four different interventions in a factorial design. The study focuses on addressing systemic inflammation and optimizing cerebral perfusion, which are critical factors in the post-cardiac arrest syndrome. Patients will receive interventions such as dexamethasone, backrest elevation, early wakeup calls, and olanzapine, all aimed at improving recovery outcomes. The trial will involve patients who have achieved sustained return of spontaneous circulation (ROSC) but remain unconscious after resuscitation.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced an OHCA of presumed cardiac cause and are unconscious after achieving sustained ROSC.

Not a fit: Patients who are not suitable for this study include those with known limitations in therapy, significant pre-existing health conditions, or those who have experienced prolonged time from ROSC to screening.

Why it matters

Potential benefit: If successful, this trial could significantly improve survival rates and neurological outcomes for patients recovering from out-of-hospital cardiac arrest.

How similar studies have performed: Previous studies have shown promise in improving outcomes for OHCA patients through various interventions, but this specific factorial design approach is relatively novel.

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

Where this trial is running

Copenhagen, Capital Region of Denmark and 4 other locations

• Dept. of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet — Copenhagen, Capital Region of Denmark, Denmark (Recruiting)
• The Department of Intensive Care, Aalborg University Hospital — Aalborg, Denmark (Recruiting)
• The Department of Intensive Care, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
• Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital — Køge, Denmark (Recruiting)
• The Department of Cardiothoracic Anaesthesiology, Odense University Hospital — Odense, Denmark (Recruiting)

Study contacts

• Principal investigator: Jesper Kjaergaard, MD PhD DMSc — Dept. of Cardiology, Rigshospitalet
• Study coordinator: Christian Hassager, MD DMSc

Conditions Out-Of-Hospital Cardiac Arrest; Post-Cardiac Arrest Syndrome; Systemic Inflammatory Response Syndrome; Inflammation; Cerebral perfusion; Sedation; Delirium