Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)

Sponsor

University of Padova (Other)

Overall Status

Completed

CT.gov ID

NCT00741663

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Ascites	Drug: Spironolactone and furosemide Drug: Spironolactone and furosemide	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 4 Study on the Comparison Between Combined Versus Sequential Diuretic Treatment of Moderate Ascites in Nonazotemic Patients With Cirrhosis

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A	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. Drug: Spironolactone and furosemide 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.
Experimental: B	Drug: Spironolactone and furosemide 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.

Arm

Intervention/Treatment

Active Comparator: A

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.

Drug: Spironolactone and furosemide

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.

Experimental: B

Drug: Spironolactone and furosemide

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.

Outcome Measures

Primary Outcome Measures

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

time to get the response to diuretics [within three weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.