CompletedPhase 2

Steroid Treatment After Resuscitated Out-of-Hospital Cardiac Arrest

Denmark158 participantsStarted 2020-10-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years
✓. OHCA of presumed cardiac cause
✓. Unconsciousness (GCS ≤8) upon pre-hospital randomization
✓. Sustained ROSC for at least 5 minutes
✓. Randomization and start of study medicine infusion within 30 minutes of sustained ROSC.

Exclusion criteria

✕. Advanced life support termination-of-resuscitation exclusion criteria
✕. Asystole as primary ECG rhythm
✕. Women of childbearing capacity
✕. Known therapy limitation
✕. Known allergy to methylprednisolone
✕. Known pre-arrest modified Rankin Scale (mRS) score of 4-5
✕. Temperature upon randomization \<30° C
✕. \>30 minutes to sustained ROSC.

What they're measuring

Concentration of IL-6

Timeframe: Daily measurements from admission to 72 hours after admission

Concentration of NSE

Timeframe: Daily measurements from admission to 72 hours after admission

Trial details

NCT IDNCT04624776

SponsorChristian Hassager

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-15

View on ClinicalTrials.gov More Out-Of-Hospital Cardiac Arrest trials