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

• Published in: Alimentary pharmacology & therapeutics Vol. 30; no. 3; pp. 227 - 235
• Main Authors: LICATA, G., TUTTOLOMONDO, A., LICATA, A., PARRINELLO, G., DI RAIMONDO, D., DI SCIACCA, R., CAMMÀ, C., CRAXÌ, A., PATERNA, S., PINTO, A.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.08.2009; Blackwell
• Subjects: Abdomen; Adult; Aged; Aged, 80 and over; Ascites - etiology; Ascites - therapy; Biological and medical sciences; Digestive system; Diuretics - therapeutic use; Dose-Response Relationship, Drug; Female; Furosemide - administration & dosage; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Liver Cirrhosis - complications; Liver Cirrhosis - physiopathology; Liver Cirrhosis - therapy; Male; Medical sciences; Middle Aged; Other diseases. Semiology; Paracentesis; Pharmacology. Drug treatments; Pilot Projects; Saline Solution, Hypertonic - administration & dosage; Treatment Outcome; Human; Treatment resistance; Effusion; Furosemide; Diuretic; Treatment; Sulfonamides; Abdominal disease; Anthranilic acid derivatives; Antihypertensive agent; Clinical trial; Ascites; High dose; Hypertonic solution; Saline solution; Comparative study; Paracentesis
• ISSN: 0269-2813; 1365-2036; 1365-2036
• DOI: 10.1111/j.1365-2036.2009.04040.x

Summary 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 H2O 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.