A Phase 2/3 interventional study of Empagliflozin 10 MG and Diuretics in Ascites Hepatic, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Alexandria University · Phase 2/3, Interventional, and Treatment
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
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.
Alexandria University is the lead sponsor of 586 studies on the registry; 128 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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)
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.
Drug: Empagliflozin 10 MG · Drug: Diuretics
Drug: Diuretics
once daily empagliflozin 10mg+/- diuretics
diuretics as clinically indicated
No need for paracentecis
Time frame: 3 months
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Empagliflozin