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The Danish Out-of-Hospital Cardiac Arrest Study

Study acronym: DANOHCA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Study sites revised (5)v6
  2. Minor Site details revised at 1 of 5 sitesv5
  3. Minor Site details revised at 1 of 5 sitesv4
  4. Minor Site details revised at 1 of 5 sitesv3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2023 to Jun 16, 2023
    • Site details revised at 5 of 5 sites
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05895838
Lead Sponsor Christian Hassager
Conditions
(from sponsor)
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Related terms Delirium, Inflammation, Out-of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome, Systemic Inflammatory Response Syndrome
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov