Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)

University of Padova

Status and phase

Completed

Phase 4

Conditions

Cirrhosis

Ascites

Treatments

Drug: Spironolactone and furosemide

Study type

Interventional

Funder types

Other

Identifiers

NCT00741663

318P

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.