Status:
COMPLETED
Empagliflozin as a Novel Therapy in Refractory Ascites
Lead Sponsor:
Alexandria University
Conditions:
Ascites Hepatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ref...
Detailed 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...
Eligibility Criteria
Inclusion
- 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)
- 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)
- 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
- 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.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05430243
Start Date
April 21 2022
End Date
November 12 2022
Last Update
November 29 2022
Active Locations (1)
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1
Alexandria University
Alexandria, Egypt, 21131