Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)

Study Overview
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Brief Summary
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The question whether the sequential diuretic therapy, that means using an antialdosteronic drug at first and adding a loop diuretic in nonresponders, is better than the combination of the two diuretics from the beginning (combined diuretic therapy) in the treatment of ascites in patients with cirrhosis is still open. Therefore, the aim of the study is to compare sequential versus combined diuretic therapy in these patients. One hundred patients will be randomized into two groups. Group A will receive potassium canrenoate at the initial dose of 200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to 150 mg/day. Group B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively. The percentage of responders to dthe diuretic treatment, the time to get the resolution of ascites and the rate of adverse effects will be compared between the two Groups of Patients.

Official Title
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Phase 4 Study on the Comparison Between Combined Versus Sequential Diuretic Treatment of Moderate Ascites in Nonazotemic Patients With Cirrhosis

Conditions
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Cirrhosis, Ascites

Intervention / Treatment
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* Drug: Spironolactone and furosemide
* Drug: Spironolactone and furosemide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade 2 ascites Serum creatinine less than 1.2 mtg/dl Serum sodium > 130 mmol/l Serum potassium within 3.5 and 4.5 mmol/l At least five days after the withdrawal of diuretics A 90 mmol/day Na diet. Exclusion Criteria: Any therapeutic paracentesis for ascites before inclusion Cardiac or respiratory disease Gastrointestinal bleeding, hepatic encephalopathy, bacterial infections in the last 4 weeks before inclusion. The use of NSAIDs or other nephrotoxic drugs in the last 4 weeks before inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Spironolactone and furosemide<br>* Patients in arm A will receive potassium canrenoate at the initial dose of 200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to 150 mg/day.<br>Drug: Spironolactone and furosemide<br>* Patients in arm B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.<br>|
| Experimental: B<br> | Drug: Spironolactone and furosemide<br>* Patients in arm B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics |  | within three weeks | 
| the percentage of patients who will respond to the diuretic treatment, the percentage of patients who will develop adverse effects to diuretics |  | within three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to get the response to diuretics |  | within three weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis, ascites, diuretic therapy, potassium canrenoate, furosemide, hyperkalemia, plasma renin activity, nitric oxide, serum sodium concentration, refractory ascites, Nonazotemic patients with cirrhosis and moderate ascites