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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites
Rate of treatment emergent adverse events assessed by physical examination and laboratory safety
Time frame: 28 day treatment period and 28 day post-treatment
Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites
Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css)
Time frame: 7 day treatment
Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin
Comparison of pre-treatment and post-treatment incidence of therapeutic paracentesis and change in volume of ascites removed
Time frame: 28 day post-treatment
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