Approximately half of all comatose patients after cardiac never regains consciousness because of severe postanoxic encephalopathy. The other half may be left with cognitive or motor disturbances. Currently, there is no effective treatment to promote cerebral recovery.
Treatment with acyl-ghrelin, a naturally occurring hormone and neurotransmitter, improved functional recovery under experimental in vivo and in vitro conditions, and decreased histologically measured neuronal damage. Ghrelin has been tested in over one hundred human studies, including studies in healthy volunteers and patients with cardiopulmonary diseases, neuro-endocrine diseases, psychiatric diseases, and neurodegenerative diseases. Serious adverse events were extremely rare and difficult to attribute to ghrelin administration.
With the Ghrelin in Coma after cardiac arrest (GRECO) trial, we aim to measure safety and efficacy of intravenous treatment with acyl-ghrelin to promote cerebral functional outcome of comatose patients after cardiac arrest.
This will be a phase 2 multicenter, double blind, placebo controlled randomized clinical trial. 160 comatose patients after cardiac arrest and successful cardiopulmonary resuscitation, admitted to intensive care units of participating hospitals, will be included within 12 hours after resuscitation. The intervention contrast will be intravenous treatment with acylated ghrelin 600micrg twice daily for 1 week vs. placebo. The primary outcome measure will be functional outcome as expressed as the score of the cerebral performance category (CPC) at 6 months. Secondary outcome measures include cognitive outcome, cardiovascular measures, and endocrinological measures. Patients will be followed during 1 year.