Clinical trial NCT00741663: Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)
Official title: Phase 4 Study on the Comparison Between Combined Versus Sequential Diuretic Treatment of Moderate Ascites in Nonazotemic Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2008-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics
timeFrame: within three weeks
measure: the percentage of patients who will respond to the diuretic treatment, the percentage of patients who will develop adverse effects to diuretics
timeFrame: within three weeks
Secondary outcomes:
measure: time to get the response to diuretics
timeFrame: within three weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova, Dept. of Clinical and Experimental Medicine
Study officials:
References:
citation: 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.
citation: 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.