Clinical Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patients With Refractory Cirrhotic Ascites
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin 5mg, Standard care treatment.
- Who it may be relevant to
- Registry conditions: Refractory Ascites. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Dapagliflozin 5mg
Dapagliflozin 5m orally once daily for 3 months plus standard care (diuretics and Large volume paracentesis) - Drug Standard care treatment
Diuretics and Large volume paracentesis as indicated
Primary outcome measures
- Difference in ascites control between the two groups at the end of treatment [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06919523 · 2025-NM