Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
TERMINATED
NCT05014087
PHASE2

Digoxin In Treatment of Alcohol Associated Hepatitis

Sponsor: Yale University

View on ClinicalTrials.gov

Summary

Prospective, single center, open label, randomized controlled trial to explore whether digoxin treatment affects cytokine levels as biomarkers of inflammation in patients with acute alcohol associated hepatitis, 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.

Official title: Digoxin In Treatment of Alcohol Associated Hepatitis (DIGIT-AlcHep)

Key Details

Gender

All

Age Range

21 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2021-10-08

Completion Date

2025-09-12

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DRUG

Intravenous digoxin

Loading dose: the total loading dose of digoxin will be determined using the Loading nomogram. The FDA-recommended total IV digoxin loading dose range is 8 to 12 mcg/kg. The lowest recommended dose of 8 mcg/kg was used in constructing the digoxin Loading nomogram that will be used in this trial. Maintenance dose: the maintenance dose will be started approximately 24 hours after initiation of digoxin loading. The post-loading digoxin trough will be reviewed prior to starting maintenance dosing. Subjects on P-gp inhibitors or spironolactone, will have an additional digoxin level performed 12-hours after any dose adjustment. Once digoxin levels are stable, 24-hour blood draws will be performed.

Locations (1)

Yale New Haven Hospital, Yale School of Medicine

New Haven, Connecticut, United States