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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05430243
• Other study ID #: 0305418
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 21, 2022
• Est. completion date: November 12, 2022

Study information

• Verified date: November 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 12, 2022
• Est. primary completion date: November 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Age older than 18 years old. 2. Ability to give a written informed consent. 3. Decompensated liver cirrhosis complicated with ascites. 4. Diagnosis of refractory ascites has made 3 months before informed consent which defined as one of the following(6)

1. Ascites that cannot be mobilized or the early recurrence of which cannot be prevented despite moderate salt restriction and maximum dose of diuretics ( furosemide 160 mg or equivalent and spironolactone 400mg)

2. Ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of the development of diuretic-induced complications that preclude the use of an effective diuretic dosage.

Exclusion Criteria:

• 1. History of any attack of hypoglycemia (defined as serum glucose less than 70 mg/dl) either symptomatic or a symptomatic.

2. Blood pressure below 90/60 or History of Hypotension requiring high dose of vasopressor therapy (more than 15mg midodrine /day) 3. Patients who receive non-selective B-blockers. 4. History of recurrent urinary tract infection defined as more than 2 infections in last 6 months 5. Pregnancy and breast feeding 6. History of hypersensitivity to any SGLT2 inhibitor 7. Presence of hepatocellular carcinoma or any other malignancy. 8. eGFR below 30 ml/min using Modification of Diet in Renal Disease study (MDRD) 9. Patients with history of diabetes mellitus complicated with diabetic ketoacidois (DKA) or patients have any risk factors for DKA 10. History of alcohol intake 11. Modified Child-Pugh score 12 or more.

Related Conditions & MeSH terms

• Ascites
• Ascites Hepatic

Intervention

Drug:
• Empagliflozin 10 MG
once daily empagliflozin 10mg+/- diuretics
• Diuretics
diuretics as clinically indicated

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No need for paracentecis		3 months