Ghrelin for Neuroprotection in Post-Cardiac Arrest Coma: A Randomized Clinical Trial.

Area of Science:

• Neurology
• Critical Care Medicine
• Cardiology

Background:

• Survival rates after out-of-hospital cardiac arrest have increased, but neurological outcomes remain suboptimal.
• Existing neuroprotective strategies have not shown definitive efficacy in comatose cardiac arrest survivors.
• Acyl-ghrelin demonstrated neuroprotective effects in preclinical models and safety in human studies.

Purpose of the Study:

• To evaluate the safety and potential efficacy of intravenous acyl-ghrelin in improving neurological outcomes for comatose patients following cardiac arrest.
• To assess the impact of acyl-ghrelin on neurological recovery and survival rates in this patient population.

Main Methods:

• A phase 2, double-blind, placebo-controlled, randomized clinical trial (GRECO) involving 160 adult comatose cardiac arrest patients.
• Patients received either intravenous acyl-ghrelin (600 μg twice daily for 7 days) or placebo, in addition to standard care.
• Primary outcome was Cerebral Performance Categories (CPC) scale score at 6 months; secondary outcomes included mortality and neuron-specific enolase (NSE) levels.

Main Results:

• Acyl-ghrelin treatment showed a trend towards improved CPC scores (OR 1.78, P=.06) and significantly reduced NSE levels on day 1 (P=.04).
• Mortality was lower in the acyl-ghrelin group (37%) compared to placebo (51%), though not statistically significant (P=.08).
• The incidence and type of serious adverse events were similar between the acyl-ghrelin and placebo groups, indicating a favorable safety profile.

Conclusions:

• Intravenous acyl-ghrelin appears to be safe and potentially effective for improving neurological outcomes in comatose patients after cardiac arrest.
• While results suggest a potential benefit, larger phase 3 trials are necessary to establish definitive efficacy and guide clinical practice.