A Phase 4 interventional study of Spironolactone and furosemide and Spironolactone and furosemide in Cirrhosis and Ascites, sponsored by University of Padova. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-09-25.
Sponsored by University of Padova · Phase 4, Interventional, and Treatment
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
Drug: Spironolactone and furosemide
Drug: Spironolactone and furosemide
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.
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.
the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics
Time frame: 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
Time frame: within three weeks
time to get the response to diuretics
Time frame: within three weeks
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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University of Padova