Physiologic Effects of Steroids in Cardiac Arrest

• Status: Completed
• Trial end date: 2018-08-11
• Target enrollment: 0
• Participant gender: All

Summary

Early stress-dose steroids are of uncertain efficacy in cardiac arrest. The current authors plan to conduct a prospective, randomized, placebo controlled evaluation of stress-dose steroids efficacy with repect to early postresuscitation hemodynamics, heart function, brain perfusion, and inflammatory response in vasopressor-requiring cardiac arrest. Patients will also be followed for organ dysfunction, potential, steroid-associated complications, and functional outcome at hospital discharge.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Athens
• Collaborator: University of Thessaly
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

Adult in-patients with ROSC [for at least 20 min] after cardiac arrest due to

• Ventricular fibrillation/pulseless tachycardia not responsive to three direct current countershocks, or

• Asystole, or

• Pulseless electrical activity.

Exclusion Criteria:

• Age <18 years

• Terminal illness (i.e. life expectancy <6 weeks e.g. due to metastatic cancer, or Sequential Organ Dysfunction Assessment score of 15 or more, or new septic complication in the presence of immunosuppression) or do-not- resuscitate status

• Cardiac arrest due to exsanguination (e.g. ruptured aortic aneurysm)

• Cardiac arrest before hospital admission

• Pre-arrest treatment with intravenous corticosteroids

• Any history of an allergic reaction

• Transmural myocardial infarction

• Previous enrollment in or exclusion from the current study.

• Confirmation of return of spontaneous circulation before study-drug administration, corresponding to "premature randomization" [reference 18] will also result in patient exclusion due to absence of vasopressor-requiring cardiac arrest.

Additional Exclusion Criteria According to the Protocol Amendment approved on January 24, 2017: Any deviation from the hospital's standard resuscitative procedure.

Pre-arrest diagnosis of an "active" peptic ulcer. Projected ICU admission time of more than 48 hours in case of a concurrent, special public health circumstance (e.g. severe flu outbreak) that may abruptly increase the demand for intensive care.