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Efficacy and Safety of empagliflozin in patients with hepatic ascites: a randomized controlled trial

Efficacy and Safety of empagliflozin in patients with hepatic ascites: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202402866059449
Enrollment
60
Registered
2024-02-01
Start date
2023-08-16
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System

Interventions

Empagliflozin
Control

Sponsors

None
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years old or older. 2. Decompensated liver cirrhosis complicated with ascites. 3.Ability to understand and willingness to participate and sign a written informed consent document

Exclusion criteria

Exclusion criteria: 1.age under 18 years old; 2.History of any attack of hypoglycemia (defined as serum glucose less than 70 mg/dl) either symptomatic or a symptomatic. 3.vitally unstable pt 4.Patients who receive non-selective B-blockers. 5.History of recurrent urinary tract infection defined as more than 2 infections in last 6 months 6.Pregnancy and breast feeding 7.History of hypersensitivity to any SGLT2 inhibitor 8.Presence of hepatocellular carcinoma or any other malignancy. 9.eGFR below 45mL/min/1.73m2 or decrease in eGFR by >30% between screening 10. Patients with history of diabetes mellitus complicated with diabetic ketoacidosis (DKA) or patients have any risk factors for DKA 12. History of alcohol intake

Design outcomes

Primary

MeasureTime frame
1- Efficacy of empagliflozin in the management of hepatic ascites improvement in the form of decreased ascites by clinical follow-up and periodic abdominal ultrasound examination, weight assessment, and urine output. 2- side effects of empagliflozin including hypoglycemia, hepatic deterioration, increased ascites, urinary tract infection, and any other adverse effects.

Secondary

MeasureTime frame
subgroup analyis according to age, sex, garde of hepatic decompenation and any other beficail subgroup analyisis.

Countries

Egypt

Contacts

Public ContactKhaled AbdelAzeem

Professor of Hepatology gastroenterology and infectious diseases AlAzhar University Assiut Egypt

drkhaledabdelazeem@gmail.com00201004575331

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026