A study to see the effect of DAPAGLIFLOZIN in cirrhosis patients with Refractory Ascites

RANDOMIZED CONTROL TRIAL OF SGLT-2 INHIBITOR (DAPAGLIFLOZIN) IN CIRRHOSIS PATIENTS WITH REFRACTORY ASCITES: A PILOT RCT DAPRA-CLD - DAPRA-CLD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079159

Enrollment

Registered

2025-01-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Dapagliflozin (10 mg/day) plus standard of care: Dapagliflozin 10mg/day will be given to the subject with the standard of care. Standard medical therapy will include dietary restriction

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cirrhosis patients with refractory ascites with Child-Turcotte-Pugh B7-C11 class Hepatic Cirrhosis (moderate-severe impaired liver function)

Exclusion criteria

Exclusion criteria: Portal vein thrombosis Hepatocellular carcinoma. Active alcoholism with last alcohol intake 1 month back Gastrointestinal bleeding in the preceding 1 month Overt hepatic encephalopathy in the preceding 1-month Documented hypoglycaemia in the preceding 1-month Serum sodium less than 125 meq/L History of skeletal fracture in the preceding year or any past history of fragility fracture History of peripheral vascular disease Acute kidney injury as defined by the International Club of Ascites criteria Spontaneous Bacterial Peritonitis within 1-month preceding the study Anatomic urologic defects that predispose to urinary tract infection Mixed ascites (additional etiology of ascites apart from portal hypertension) Any severe extra hepatic condition including respiratory and cardiac failure Acute-on-chronic liver failure as per either the APASL or CANONIC criteria Treatment with drug with known effects on systemic and renal hemodynamics within 7 days of inclusion except beta-blockers Patients opting for a liver transplant or TIPS Refusal to give consent

Design outcomes

Primary

Measure	Time frame
Comparison of control of ascites at 3 months between the 2 groupsTimepoint: 3 months	—

Secondary

Measure	Time frame
1. Change in eGFR measured by MDRD-6 at 1, 2 and 3 months 2. Change in urine output at 2 -weeks, 1, 2 and 3 months 3. Changes in serum and 24-hour urine sodium at 2-weeks, 1, 2 and 3 months 4. Change in HbA1c at 3-months 5. Change in prognostic scores – MELD score and CTP score at 1, 2 and 3 months 6. Change in Hemodynamic Parameters: Cardiac Output, MAP and Systemic Vascular resistance at 3-months 7. Incidence of overt hepatic encephalopathy over 3-months 8. Incidence of AKI as per ICA criteria over 3-months 9. Incidence of SBP, UTI and other infections over 3-monthsTimepoint: 1. 3 month 2. 3 month 3. 3 month 4. 3 month 5. 3 month 6. 3 month 7. 3 month 8. 3 month 9. 3 month	—

Measure

Time frame

1. Change in eGFR measured by MDRD-6 at 1, 2 and 3 months 2. Change in urine output at 2 -weeks, 1, 2 and 3 months 3. Changes in serum and 24-hour urine sodium at 2-weeks, 1, 2 and 3 months 4. Change in HbA1c at 3-months 5. Change in prognostic scores – MELD score and CTP score at 1, 2 and 3 months 6. Change in Hemodynamic Parameters: Cardiac Output, MAP and Systemic Vascular resistance at 3-months 7. Incidence of overt hepatic encephalopathy over 3-months 8. Incidence of AKI as per ICA criteria over 3-months 9. Incidence of SBP, UTI and other infections over 3-monthsTimepoint: 1. 3 month 2. 3 month 3. 3 month 4. 3 month 5. 3 month 6. 3 month 7. 3 month 8. 3 month 9. 3 month

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Countries

India

Contacts

Public ContactDr Pranjal SIngh

All India Institute of Medical Sciences

pranjal96@gmail.com8826433805

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026