Alcohol-Induced Disorders Clinical Trial
Official title:
Digoxin In Treatment of Alcohol Associated Hepatitis (DIGIT-AlcHep)
Prospective, single center, open label, randomized controlled trial to determine the feasibility of conducting a future study with respect to patient recruitment, digoxin administration and dose adjustment. The study intervention will be intravenous digoxin (renal-based dosing for maximum of 28 days) versus no digoxin in an open-label 1:1 randomized allocation of patients with severe acute alcohol associated hepatitis.
Severe alcohol associated hepatitis is a condition of acute on chronic immune liver dysfunction that is associated with high mortality, necessitating a search for drugs that may prove safe and efficacious in treating this disease. Pre-clinical studies suggest that digoxin, which is currently used for treating cardiac conditions, is also effective in improving alcohol-associated liver injury. To date, there have been no clinical studies of digoxin use in patients with alcohol associated hepatitis. The primary objective of this study of digoxin versus no digoxin in patients with severe alcohol associated hepatitis is to assess the feasibility of conducting a large randomized trial to detect efficacy with respect to patient recruitment, digoxin administration and dose adjustment in patients hospitalized with severe alcohol associated hepatitis. ;
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