Status:
COMPLETED
IL-6 Inhibition for Modulating Inflammation After Cardiac Arrest
Lead Sponsor:
Christian Hassager
Conditions:
Heart Arrest
Out-Of-Hospital Cardiac Arrest
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Resuscitated cardiac arrest is associated with a systemic inflammatory response that is directly associated with poor prognosis. Inhibition of the IL-6 mediated immune response may potentially inhibit...
Detailed Description
INTRODUCTION AND BACKGROUND: The incidence of out-of-hospital cardiac arrest (OHCA) in Denmark is approximately 4,000 per year, and the mortality remains approximately 90%. Furthermore, in the approx...
Eligibility Criteria
Inclusion
- Each of the following criteria must be fulfilled for a subject to be eligible:
- Age ≥ 18 years
- OHCA of a presumed cardiac cause
- Unconsciousness upon admission, i.e. a GCS \< 9
- Sustained ROSC for more than 20 minutes
Exclusion
- None of the following criteria must be fulfilled for a subject to be eligible:
- Consciousness upon admission, i.e. a GCS ≥ 9
- Presumed non-cardiac cause of arrest
- Unwitnessed asystole
- Suspected or confirmed intracranial bleeding or stroke
- Pregnancy, or females in fertile age, unless a negative serum HCG can rule out pregnancy within the inclusion window.
- Temperature on admission \< 30 °C
- Persistent cardiogenic shock\* that is not reversed within the inclusion window
- Known disease making 180 day survival unlikely
- Known limitations in therapy
- Known pre-arrest Cerebral Performance Category of 3 to 4
- \> 240 minutes from ROSC to randomization
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03863015
Start Date
March 4 2019
End Date
June 30 2020
Last Update
August 21 2020
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100