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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
History of Changes
  Purpose

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 Intervention Phase
Cirrhosis
Ascites
 Drug: Spironolactone and furosemide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Potassium
U.S. FDA Resources

Further study details as provided by University of Padova:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • time to get the response to diuretics [ Time Frame: within three weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741663

Locations
Italy
University of Padova, Dept. of Clinical and Experimental Medicine
Padova, Italy, 35100
Sponsors and Collaborators
University of Padova
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Paolo Angeli, Dept. of Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT00741663     History of Changes
Other Study ID Numbers: 318P
Study First Received: August 22, 2008
Last Updated: September 24, 2008
Health Authority: Italy: National Istitute of Health

Keywords provided by University of Padova:
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

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Canrenoate Potassium
Spironolactone
Diuretics
Furosemide
Aldosterone Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Natriuretic Agents
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013