Cirrhosis Clinical Trial
Official title:
Phase 4 Study on the Comparison Between Combined Versus Sequential Diuretic Treatment of Moderate Ascites in Nonazotemic Patients With Cirrhosis
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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