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The Danish Out-of-Hospital Cardiac Arrest Study

RecruitingPhase 3Ages 18 Years - anyAllChristian Hassager
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ18 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 \<30ยฐC 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
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What it tests

  • Dexamethasone
  • Backrest elevation
  • Early wakeup call
  • Olanzapine
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Where

5 sites
Dept. of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
The Department of Intensive Care, Aalborg University Hospital
Aalborg, Denmark
The Department of Intensive Care, Aarhus University Hospital
Aarhus, Denmark
Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital
Kรธge, Denmark
The Department of Cardiothoracic Anaesthesiology, Odense University Hospital
Odense, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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