Efficacy and Safety of empagliflozin in patients with hepatic ascites: a randomized controlled trial
- Conditions
- Digestive System
- Registration Number
- PACTR202402866059449
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method subgroup analyis according to age, sex, garde of hepatic decompenation and any other beficail subgroup analyisis.