Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)

This study has been completed.
Sponsor:
Information provided by:
University of Padova
ClinicalTrials.gov Identifier:
NCT00741663
First received: August 22, 2008
Last updated: September 24, 2008
Last verified: September 2008

August 22, 2008
September 24, 2008
April 2005
September 2008   (final data collection date for primary outcome measure)
  • the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics [ Time Frame: within three weeks ] [ Designated as safety issue: Yes ]
  • the percentage of patients who will respond to the diuretic treatment, the percentage of patients who will develop adverse effects to diuretics [ Time Frame: within three weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00741663 on ClinicalTrials.gov Archive Site
time to get the response to diuretics [ Time Frame: within three weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)
Phase 4 Study on the Comparison Between Combined Versus Sequential Diuretic Treatment of Moderate Ascites in Nonazotemic Patients With Cirrhosis

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cirrhosis
  • Ascites
  • 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.
  • Active Comparator: A
    Interventions:
    • Drug: Spironolactone and furosemide
    • Drug: Spironolactone and furosemide
  • Experimental: B
    Intervention: Drug: Spironolactone and furosemide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00741663
318P
No
Prof. Paolo Angeli, Dept. of Clinical and Experimental Medicine
University of Padova
Not Provided
Not Provided
University of Padova
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP