Actively Recruiting
The Danish Out-of-Hospital Cardiac Arrest Study A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating Dexamethasone, Olanzapine, Backrest Elevation, and Early Wakeup Interventions in Comatose Cardiac Arrest Patients
Led by Christian Hassager · Updated on 2025-01-24
1000
Participants Needed
5
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients who have been resuscitated after an Out-of-Hospital Cardiac Arrest (OHCA) and suffer from Post Cardiac Arrest Syndrome, which involves systemic inflammation, brain and heart dysfunction, and the original cause of the arrest. This phase III trial aims to improve outcomes for unconscious OHCA patients by testing four different interventions that target inflammation, brain blood flow, sedation duration, and delirium prevention. The study hopes to reduce the high death rate mainly caused by brain injury in these patients. The trial randomly assigns about 1000 patients to receive one of four interventions: high-dose steroids (dexamethasone) or placebo to reduce inflammation; backrest elevation at 5 degrees or 35 degrees during sedation; early wakeup and potential extubation after 6 hours or standard timing at 28-36 hours; and prophylactic olanzapine or placebo to prevent delirium. Steroids and olanzapine are given in three doses. The backrest position is maintained for up to 72 hours or until extubation. Wakeup timing differs between groups and follows specific clinical criteria. Participants will be closely monitored in intensive care with regular checks of their backrest position, sedation levels, and heart rhythm for 96 hours. Researchers will measure mortality at 90 days for the steroid and backrest interventions, and days alive outside the hospital within 30 days for the wakeup and olanzapine interventions. The study includes detailed assessments of brain function, sedation, and delirium, aiming to gather comprehensive data on treatment safety and effectiveness over several months.
CONDITIONS
Official Title
The Danish Out-of-Hospital Cardiac Arrest Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Out-of-Hospital Cardiac Arrest (OHCA) of presumed cardiac cause
- Sustained return of spontaneous circulation (ROSC) with stable signs of circulation for at least 20 minutes without chest compressions or mechanical support
- Unconsciousness with Glasgow Coma Scale less than 9 after ROSC at randomization
You will not qualify if you...
- Females of childbearing potential if pregnancy is suspected without a negative pregnancy test
- Known bleeding disorders (except medically induced coagulopathy such as warfarin, NOAC, clopidogrel use)
- Suspected or confirmed acute brain bleeding
- Suspected or confirmed acute stroke
- Unwitnessed asystole
- Known limits on therapy or Do Not Resuscitate order
- Diseases making 180-day survival unlikely
- Poor pre-arrest brain function (CPC 3 or 4)
- More than 3 hours from ROSC to screening
- Low systolic blood pressure below 80 mm Hg despite treatment unless recovering within 180 minutes
- Use of intra-aortic balloon pump, axial flow device, or ECMO unless removed within 180 minutes
- Body temperature below 30°C on admission
- Allergy to dexamethasone or olanzapine
- Treatment with olanzapine or dexamethasone within 48 hours
- Known back or hip problems preventing backrest positioning
- Known or suspected Long QT Syndrome
- Active fungal infection (localized skin lesions allowed)
- Estimated body weight less than 45 kg
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Dept. of Cardiology, The Heart Centre, Copenhagen University Hospital Rigshospitalet
Copenhagen, Capital Region of Denmark, Denmark, DK-2100
Actively Recruiting
2
The Department of Intensive Care, Aalborg University Hospital
Aalborg, Denmark, DK-9000
Actively Recruiting
3
The Department of Intensive Care, Aarhus University Hospital
Aarhus, Denmark, DK-8200
Actively Recruiting
4
Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital
Køge, Denmark, DK-4600
Actively Recruiting
5
The Department of Cardiothoracic Anaesthesiology, Odense University Hospital
Odense, Denmark, DK-5000
Actively Recruiting
Research Team
C
Christian Hassager, MD DMSc
J
Jesper Kjaergaard, MD PhD DMSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
8
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