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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


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 diuretics

the 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


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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