Clinical Trial: High-dose furosemide plus small-volume hypertonic saline solutions vs. repeated paracentesis as treatment of refractory ascites.

BACKGROUND: In patients with cirrhosis, ascites is defined as refractory when it cannot be mobilized or recurs early in standard diuretic therapy. AIM: To compare the safety and efficacy of intravenous high-dose furosemide + hypertonic saline solutions (HSS) with repeated paracentesis in patients with cirrhosis and refractory ascites. PATIENTS AND METHODS: Eighty-four subjects (59/25 M/F) with cirrhosis, mostly of viral aetiology, admitted for refractory ascites, were randomly assigned to receive furosemide (250-1000 mg/bid i.v.) plus HSS (150 mL H(2)O with NaCl 1.4-4.6% or 239-187 mEq/L) (60 patients, Group A) or to repeated paracentesis and a standard diuretic schedule (24 patients, Group B).
RESULTS: During hospitalization, Group A patients had more diuresis (1605 +/- 131 mL vs. 532 +/- 124 mL than Group B patients; P < 0.001) and a greater loss of weight at discharge (-8.8 +/- 4.8 kg vs. -4.5 +/- 3.8 kg, P < 0.00). Control of ascites, pleural effusions and/or leg oedema was deemed significantly better in Group A.
CONCLUSIONS: This randomized pilot study suggests that HHS plus high-dose furosemide is a safe and effective alternative to repeated paracentesis when treating hospitalized patients with cirrhosis and refractory ascites. Larger studies will be needed to evaluate long-term outcomes such as readmission and mortality.

RCT Entities:   Population Interventions Outcomes