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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin group | Experimental |
| |
| Standard care only group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 5mg | Drug | Dapagliflozin 5m orally once daily for 3 months plus standard care (diuretics and Large volume paracentesis) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in ascites control between the two groups at the end of treatment | Complete response: Disappearance of ascites. Partial response: Presence of ascites not requiring LVP. No response: Presence of ascites requiring LVP. | 3 months |
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Inclusion Criteria:
Adults >18 years diagnosed with decompensated liver cirrhosis complicated with ascites grade 2.
Refractory ascites defined as one of the following:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Standard care treatment | Drug | Diuretics and Large volume paracentesis as indicated |
|