Condition: Out-Of-Hospital Cardiac Arrest · Post-Cardiac Arrest Syndrome · Sponsor: Christian Hassager
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 e…
This description comes directly from the study's public registry record.
Christian Hassager, MD DMSc · +4535450572 · christian.hassager@regionh.dk
Jesper Kjaergaard, MD PhD DMSc · +4535450969 · jesper.kjaergaard.05@regionh.dk
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| 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 |
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Source record: clinicaltrials.gov/study/NCT05895838