Randomized trial comparing human albumin and hydroxyethyl starch 6% as plasma expanders for treatment of patients with liver cirrhosis and tense ascites following large volume paracentesis

Abstract

Background and study aims Cirrhosis is the commonest cause of ascites accounting for almost 85% of all cases. Approximately 10% of patients with cirrhosis develop diuretic-resistant tense ascites that requires other therapeutic interventions. Large-volume paracentesis with plasma expander infusion, mainly albumin, has been used for the management of ascites in cirrhotic patients. We aimed at investigating whether human albumin can be substituted by a less expensive plasma expander, hydroxyethyl starch 6% following paracentesis. Patients and methods One-hundred and thirty-five patients (60% with cirrhosis and schistosomal periportal fibrosis combined, 26.7% with posthepatitic cirrhosis and 13.3% with schistosomal periportal fibrosis) with tense ascites were randomized to treatment by one-session of a nearly-total paracentesis plus intravenous human albumin (68 patients) or hydroxyethyl starch 6% (67 patients). These were given at a dose of 8 g/l of ascitic fluid removed. The two groups were compared for incidence of complications, recurrence of massive ascites after hospital dismissal and survival rate. Results Both groups showed no significant changes in renal or hepatic function or serum electrolytes. The incidence of complications following paracentesis was similar in both groups. The number of readmissions during follow up and causes of readmission and survival were also comparable. The effect of paracentesis on the effective intravascular volume was indirectly assessed by plasma renin activity and plasma aldosterone concentration before treatment, 2 and 6 days after treatment. None of the mean values of these changed significantly in the two groups after paracentesis. Postparacentesis transient hypotension was observed more in the hydroxyethyl starch 6% group than in those treated with albumin (23.9% versus 8.8%, p = 0.018). Conclusions Hydroxyethyl starch 6% is safe and as effective as human albumin in protecting patients treated with nearly-total paracentesis from developing renal and electrolyte complications. Transient hypotension following paracentesis was, however, commoner in the hydroxyethyl starch group.