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This study aims to evaluate beneficial effects of using dapagliflozin in cirrhotic chronic liver disease patients. We hypnotized that the use of dapagliflozin will be associated with fewer need for large volume paracentesis hence better control of ascites, fewer need for ICU admissions, improvement of patient quality of life, better healthcare cost saving and reduced mortality rate.
Patients diagnosed with cirrhosis and any degree of ascites that led to previous or recent hospital admission and met the inclusion criteria will be randomized into two patient groups. The first patients' group, Group A, will receive standard of care (SoC) regimen only. The SoC included dietary sodium restriction, treatment with diuretics [combination of a loop diuretic (furosemide 40-160 mg/day or torsemide 5-20 mg/day) and a distal-acting diuretic (spironolactone 50-400 mg/day)] and LVP as needed. The second patients' group, group B, will receive dapagliflozin in addition to standard of care regimen. Based on the pharmacokinetic data of dapagliflozin; Patient with Child Pugh score A and B will receive 10mg/day and patients with Child Pugh score C will receive 5 mg/day. Patients will be counseled to stay adequately hydrated and avoid alcohol intake at baseline and at every follow-up visit. Adherence, body weight, symptoms of urinary tract infection, and Sodium level will be measured after 1 and 2 weeks from the start of the therapy then at the end of the follow-up period. At the start of participation and at the end of follow up period, a quality of life will be assessed using quality of life questionnaire for chronic liver disease patients. The patient will be interviewed by the principal investigator to fill the questionnaire to ensure understanding of each question.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | No Intervention | Patients will receive standard of care (SoC) regimen only. The SoC included dietary sodium restriction, treatment with diuretics [combination of a loop diuretic (furosemide 40-160 mg/day or torsemide 5-20 mg/day) and a distal-acting diuretic (spironolactone 50-400 mg/day)] and large volume paracentesis as needed. | |
| Group B | Experimental | Patients will receive dapagliflozin in addition to standard of care regimen. Based on the pharmacokinetic data of dapagliflozin; Patient with Child Pugh score A and B will receive 10mg/day and patients with Child Pugh score C will receive 5 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Dapagliflozin is sodium glucose cotransporter type 2 inhibitors (SGLT-2i) primary an antidiabetic drug but now used in chronic heart failure and chronic kidney disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of times patient need Paracentesis to control Ascites | Decrease need for large volume paracentesis in the intervention group than in the control group which indicate better control of Ascites within 3 months from the start of intervention. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of Cirrhosis sequelae | • Reduced incidence of Cirrhosis sequelae (hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, variceal bleeding) in the intervention group as compared to control group. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life using SF-36 questionnaire | • Improvement of patient quality of life in the intervention group as compared to control group. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raghda Roshdy | Contact | +0282-2162135 | Raghda.hussien@pharm.bsu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haram Hospital | Recruiting | Giza | 12556 | Egypt |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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An open label prospective parallel two group randomized controlled superiority trials.
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