Status:
NOT_YET_RECRUITING
Clinical Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patients With Refractory Cirrhotic Ascites
Lead Sponsor:
Mansoura University
Conditions:
Refractory Ascites
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this clinical trial is to evaluate the safety and efficacy of low dose dapagliflozin use along with standard care versus the standard care alone in improving the clinical outcomes of patien...
Eligibility Criteria
Inclusion
- Adults \>18 years diagnosed with decompensated liver cirrhosis complicated with ascites grade 2.
- Refractory ascites defined as one of the following:
- Ascites cannot be mobilized despite adherence to low sodium diet of ≤88 mmol/day for ≥1 week and maximum diuretic treatment dose (spironolactone 400 mg/day or furosemide (160 mg/day).
- Recurrence can't be prevented by medical therapy, Re-appearance of grade 2 or moderate ascites with moderate symmetrical abdominal distention, or grade 3 with massive ascites with marked abdominal distention within 4 weeks of initial mobilization.
Exclusion
- Presenting blood pressure below 90/60 or history of hypotension requires vasopressor treatment.
- History of recurrent urinary tract infections, defined by the occurrence of 2 or more acute UTIs within months or 3 within a year.
- History of hypersensitivity to SGLT2 inhibitors.
- History of diabetic ketoacidosis or presence of risk factors for DKA (i.e alcohol consumption, type 1 diabetes).
- Pregnant or lactating women.
- History of recurrent episodes of hypoglycemia defined as plasma glucose concentration \<70mg/dL.
- Severe renal dysfunction defined as, eGFR \<20 ml/min/1.73m2.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06919523
Start Date
April 15 2025
End Date
September 15 2025
Last Update
April 9 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.