Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)

Phase 4

Completed

• Conditions: Cirrhosis; Ascites
• Interventions: Drug: Spironolactone and furosemide

• Registration Number: NCT00741663
• Lead Sponsor: University of Padova

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2008-09-24
• Last Update Posted: 2008-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Spironolactone and furosemide	-
B	Spironolactone and furosemide	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
time to get the response to diuretics	within three weeks

Trial Locations

Locations (1)

University of Padova, Dept. of Clinical and Experimental Medicine; 🇮🇹 Padova, Italy