Efficacy and safety of the stepped care medical treatment of ascites in liver cirrhosis: a randomized controlled clinical trial comparing two diets with different sodium content.
In order to clarify debated issues of the medical treatment of ascites in cirrhosis--the usefulness of a low sodium diet and washout period preceding diuretic administration, maximal dosage of antimineralocorticoid to be reached before the addition of a loop diuretic, identifications of factors influencing treatment efficacy--115 hospitalized patients with non-azotemic cirrhosis and ascites were recruited and randomized to receive a diet providing either 40 or 120 mmol of sodium daily. After a washout period from the outpatient diuretic regimen for 7 days (Step 1), increasing dosages of K-canrenoate (200 mg/day every 4th day up to 600 mg) were administered to patients not undergoing spontaneous diuresis (Step 2). Upon the failure of Step 2, K-canrenoate (400 mg/day) and furosemide at increasing dosage (25-50-100 mg every other day) were given (Step 3). Nine percent of patients underwent spontaneous diuresis, and 77% developed a negative sodium balance by the end of Step 2 (69% with a dosage of K-canrenoate < or = 400 mg/day) and 93% by the end of Step 3. Two patients were withdrawn from the protocol due to diuretic side-effects. Univariate analysis showed that the type of diet did not influence the response to treatment. The washout period led to a significant increase in endogenous creatinine clearance; natremia significantly rose in hyponatremic patients. Multivariate analysis showed that creatinine clearance and plasma aldosterone were independent predictive factors of the response to treatment.(ABSTRACT TRUNCATED AT 250 WORDS)
Bernardi
M
M
Cattedra di Patologia Speciale Medica I, University of Bologna, Italy.
Laffi
G
G
Salvagnini
M
M
Azzena
G
G
Bonato
S
S
Marra
F
F
Trevisani
F
F
Gasbarrini
G
G
Naccarato
R
R
Gentilini
P
P
D001201:Ascites / Q000178:diet therapy* / Q000188:drug therapy / Q000453:epidemiology; D002191:Canrenoic Acid / Q000627:therapeutic use; D004039:Diet, Sodium-Restricted; D005260:Female; D005665:Furosemide / Q000627:therapeutic use; D006801:Humans; D008103:Liver Cirrhosis / Q000178:diet therapy* / Q000188:drug therapy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012982:Sodium, Dietary / Q000008:administration & dosage
D012982:Sodium, Dietary; D005665:Furosemide; D002191:Canrenoic Acid