Refractory Ascites
Conditions
Keywords
Refractory ascites, Dapagliflozin
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 patients with cirrhotic refractory ascites. The main question it aims to answer is the difference in ascites control between the two groups at the end of treatment defined as: Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP. Researchers will compare intervention group receiving dapagliflozin 5m once daily for 3 months along with standard care versus standard care group to evaluate the effectiveness and safety of dapagliflozin in refractory ascites patients.
Interventions
Dapagliflozin 5m orally once daily for 3 months plus standard care (diuretics and Large volume paracentesis)
Diuretics and Large volume paracentesis as indicated
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \>18 years diagnosed with decompensated liver cirrhosis complicated with ascites grade 2. * Refractory ascites defined as one of the following: 1. 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). 2. 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in ascites control between the two groups at the end of treatment | 3 months | Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP. |
Outcome results
None listed