Empagliflozin as a Novel Therapy in Refractory Ascites

Ascites Hepatic Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Ascites
• Ascites Hepatic

• NCT number: NCT05430243
• Study type: Interventional
• Source: Alexandria University
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 21, 2022
• Completion date: November 12, 2022