Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)

Cirrhosis Clinical Trial

— SVSSF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741663
• Other study ID #: 318P
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2008
• Last updated: September 24, 2008
• Start date: April 2005
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Istitute of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Cirrhosis
• Liver Cirrhosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	University of Padova, Dept. of Clinical and Experimental Medicine	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Santos J, Planas R, Pardo A, Durández R, Cabré E, Morillas RM, Granada ML, Jiménez JA, Quintero E, Gassull MA. Spironolactone alone or in combination with furosemide in the treatment of moderate ascites in nonazotemic cirrhosis. A randomized comparative s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics		within three weeks	Yes
Primary	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	Yes
Secondary	time to get the response to diuretics		within three weeks	No