Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)

NCT ID: NCT00741663

Last Updated: 2008-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2008-09-30

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.

Conditions

Cirrhosis; Ascites

Keywords

cirrhosis; ascites; diuretic therapy; potassium canrenoate; furosemide; hyperkalemia; plasma renin activity; nitric oxide; serum sodium concentration; refractory ascites; Nonazotemic patients with cirrhosis and moderate ascites

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

Spironolactone and furosemide

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

B

Group Type: EXPERIMENTAL

Spironolactone and furosemide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Clinical and Experimental Medicine

Locations

University of Padova, Dept. of Clinical and Experimental Medicine

Padua, , Italy

Countries

Italy

References

Santos J, Planas R, Pardo A, Durandez R, Cabre E, Morillas RM, Granada ML, Jimenez JA, Quintero E, Gassull MA. Spironolactone alone or in combination with furosemide in the treatment of moderate ascites in nonazotemic cirrhosis. A randomized comparative study of efficacy and safety. J Hepatol. 2003 Aug;39(2):187-92. doi: 10.1016/s0168-8278(03)00188-0.

Reference Type: RESULT

PMID: 12873814 (View on PubMed)

Angeli P, Fasolato S, Mazza E, Okolicsanyi L, Maresio G, Velo E, Galioto A, Salinas F, D'Aquino M, Sticca A, Gatta A. Combined versus sequential diuretic treatment of ascites in non-azotaemic patients with cirrhosis: results of an open randomised clinical trial. Gut. 2010 Jan;59(1):98-104. doi: 10.1136/gut.2008.176495.

Reference Type: DERIVED

PMID: 19570764 (View on PubMed)

Other Identifiers

318P

Identifier Type: -

Identifier Source: org_study_id