Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)
Information source: University of Padova
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis; Ascites
Intervention: Spironolactone and furosemide (Drug); Spironolactone and furosemide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Padova
Summary
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.
Clinical Details
Official title: Phase 4 Study on the Comparison Between Combined Versus Sequential Diuretic Treatment of Moderate Ascites in Nonazotemic Patients With Cirrhosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diureticsthe percentage of patients who will respond to the diuretic treatment, the percentage of patients who will develop adverse effects to diuretics
Secondary outcome: time to get the response to diuretics
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University of Padova, Dept. of Clinical and Experimental Medicine, Padova 35100, Italy
Additional Information
Starting date: April 2005
Last updated: September 24, 2008
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