NCT05430243

Empagliflozin as a Novel Therapy in Refractory Ascites

Empagliflozin in the Management of Cirrhosis-related Refractory Ascites: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present study is to investigate the safety, efficacy and cost-effectiveness of empagliflozin, a sodium glucose transporter 2 inhibitor, as an add on therapy to the standard care for refractory ascites in patients with liver cirrhosis

Detailed description

Midodrine will be added if the blood pressure less than 100/70 mmHg during the follow up period (start by dose 5 mg three times daily and up titrate the dose according to the blood pressure monitoring to maximum dose 12.5 mg three times daily. * Treatment of empagliflozin will be stopped if patient developed any of the following (attack of symptomatic hypoglycemia, hypotention not responding vasopresser agent, complicated urinary tract infection or attack of diabetic ketoascidosis) . * The dose of diuretics will be reduced if marked weight reduction occurred (more than 0.5 kilogram/day in patient with ascites only or more than 1 killogram /day in patients with ascites and lower limb edema). * The diuretics will be stopped temporally if any of the following (renal impairment, attack of hepatic encephalopathy, severe electrolyte imbalance) and permanently if the urine sodium \< 30 mEq per day or there are intolerable side effects.

Conditions

• Ascites Hepatic

Interventions

Type	Name	Description
DRUG	Empagliflozin 10 MG	once daily empagliflozin 10mg+/- diuretics
DRUG	Diuretics	diuretics as clinically indicated

Timeline

• Start date: 2022-04-21
• Primary completion: 2022-11-12
• Completion: 2022-11-12
• First posted: 2022-06-24
• Last updated: 2022-11-29

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study