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Completed

NCT Number: NCT00741663

Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)

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.

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Key information

Conditions

Cirrhosis Ascites Fibrosis Hyperkalemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Padova, Dept. of Clinical and Experimental Medicine

Padova, 35100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spironolactone and furosemide

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.

Primary outcomes

  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 outcomes

  1. time to get the response to diuretics

    Time frame: within three weeks

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Acronym: SVSSF

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 26, 2008
Registry last updated
Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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