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Spironolactone Versus Spironolactone Plus Furosemide (SVSSF) (SVSSF)

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ClinicalTrials.gov Identifier: NCT00741663
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : September 25, 2008
Sponsor:
Information provided by:
University of Padova

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 Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis Potassium

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.




Primary Outcome Measures :
  1. the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics [ Time Frame: within three weeks ]
  2. 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 ]

Secondary Outcome Measures :
  1. time to get the response to diuretics [ Time Frame: within three weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741663


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

Publications of Results:
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
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2008

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:
Fibrosis
Liver Cirrhosis
Ascites
Pathologic Processes
Liver Diseases
Digestive System Diseases
Furosemide
Diuretics
Spironolactone
Canrenoic Acid
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing