SING STEROID TREATMENT TO INHIBIT INFLAMMATION AND BRAIN INJURY IN PATIENTS RESUSCITATED FROM CARDIAC ARREST.
- Conditions
- We investigate the efficacy of commercially available glucocorticoid methylprednisolone (Solu-Medrol) for reducing the systemic inflammatory response and neurological injury in patients resuscitated after out-of-hospital cardiac arrest.MedDRA version: 20.0Level: LLTClassification code 10003109Term: Arrest cardiacSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-000855-11-DK
- Lead Sponsor
- Department of Cardiology, Copenhagen University Hospital Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
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 within 30 minutes of sustained ROSC
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
1.Advanced life support TOR exclusion criteria
2.Asystole as primary ECG rhythm
3.Female of child bearing potential (female aged 15-40, decided by the treating physician)
4.Known therapy limitation (known decision made of no resuscitation or intensive therapy)
5.Known allergy to glucocorticoid
6.Known disease making 180-day survival unlikely
7.Known pre-arrest modified Rankin Scale (mRS) score of 4-5
8.Temperature upon admission <30° C
9.>30 minutes to sustained ROSC
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method