IL-6 Inhibition for Modulating Inflammation After Cardiac Arrest

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

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 the systemic inflammatory response, potentially improving the prognosis of these severely ill patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christian Hassager

Criteria

Inclusion Criteria:

Each of the following criteria must be fulfilled for a subject to be eligible:

1. Age ≥ 18 years

2. OHCA of a presumed cardiac cause

3. Unconsciousness upon admission, i.e. a GCS < 9

4. Sustained ROSC for more than 20 minutes

Exclusion Criteria:

None of the following criteria must be fulfilled for a subject to be eligible:

1. Consciousness upon admission, i.e. a GCS ≥ 9

2. Presumed non-cardiac cause of arrest

3. Unwitnessed asystole

4. Suspected or confirmed intracranial bleeding or stroke

5. Pregnancy, or females in fertile age, unless a negative serum HCG can rule out pregnancy within the inclusion window.

6. Temperature on admission < 30 °C

7. Persistent cardiogenic shock* that is not reversed within the inclusion window

8. Known disease making 180 day survival unlikely

9. Known limitations in therapy

10. Known pre-arrest Cerebral Performance Category of 3 to 4

11. > 240 minutes from ROSC to randomization