Steroid Treatment After Resuscitated Out-of-Hospital Cardiac Arrest

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Comatose patients resuscitated from Out-of-Hospital Cardiac Arrest (OHCA) often develop a complicated systemic inflammatory response and have a poor prognosis with neurological damage being the most common cause of death. This study will investigate the anti-inflammatory and neuroprotective effect of early treatment with the glucocorticoid methylprednisolone measured by interleukin-6 and neuron-specific enolase levels in resuscitated comatose OHCA-patients.

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

Details

• Lead Sponsor: Christian Hassager
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. Age ≥18 years

2. OHCA of presumed cardiac cause

3. Unconsciousness (GCS ≤8) upon pre-hospital randomization

4. Sustained ROSC for at least 5 minutes

5. Randomization and start of study medicine infusion within 30 minutes of sustained ROSC.

Exclusion Criteria:

1. Advanced life support termination-of-resuscitation exclusion criteria

2. Asystole as primary ECG rhythm

3. Women of childbearing capacity

4. Known therapy limitation

5. Known allergy to methylprednisolone

6. Known pre-arrest modified Rankin Scale (mRS) score of 4-5

7. Temperature upon randomization <30° C

8. >30 minutes to sustained ROSC.