Cirrhosis Clinical Trial
Official title:
Safety and Efficacy of Low-dose Terlipressin Delivered by Continuous Intravenous Infusion in Patients With Cirrhosis and Ascites Refractory to, or Intolerant of, Diuretic Therapy, Requiring Large Volume Paracentesis
Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.
Terlipressin continuous infusion will be adminstered via an ambulatory pump initially for 7 days in a clinical pharmacology unit. Serial blood draws for pharmacokinetic analysis will be performed to determine steady state concentration of both terlipressin and 8-lysine-vasopressin during infusion. After establishing safety and tolerance of infusion for 7 days, patients will be transitioned to an outpatient setting where they will be treated with terlipressin continuous infusion for an additional 21 days, monitored daily by home care nurses. A total of 6 patients will be treated. Monitoring will include successful management of ascites, with reduction in paracentesis procedures and decreased ascites fluid volume, further supported by improvement in renal function. ;
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