None listed
Conditions
Brief summary
Although most patients with cirrhosis complicated by ascites initially respond to salt restriction and diuretics, as their liver disease progresses many lose diuretic responsiveness and develop refractory ascites, a condition for which there is no established drug treatment. Terlipressin is a synthetic analogue of vasopressin that causes splanchnic vasoconstriction, consequently improving renal blood flow and kidney function, and thus may ameliorate many of the pathophysiological changes that result in ascites formation. Its short half-life and bolus dose administration have previously precluded its long term use to treat ascites or other complications of cirrhosis. We performed a 4 week prospective trial of outpatient continuous terlipressin infusion in 5 patients with refractory ascites to examine its safety, practicality and efficacy in reducing ascites formation.
Interventions
Patient were admitted to hospital for placement of a peripherally inserted central cannula (PICC) line.
A terlipressin (Lucassin Registered Trademark ) infusion was commenced (1.7mg/12 hours via a syringe driver and subjects were observed in hospital for 24 hours to confirm tolerability.
The following day they were discharged home on an ambulatory terlipressin infusion which was then continued for 28 days.
Hospital-in-the-home nursing staff would visit each patient twice a day to exchange the
Patient were admitted to hospital for placement of a peripherally inserted central cannula (PICC) line. A terlipressin (Lucassin Registered Trademark ) infusion was commenced (1.7mg/12 hours via a syringe driver and subjects were observed in hospital for 24 hours to confirm tolerability. The following day they were discharged home on an ambulatory terlipressin infusion which was then continued for 28 days. Hospital-in-the-home nursing staff would visit each patient twice a day to exchange the terlipressin infusion syringe(1.7mg/12 hours) and monitor for adverse events and ensure medication delivery.
Sponsors
Paul Gow
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria were refractory ascites secondary to cirrhosis requiring at least fortnightly large volume paracentesis and age greater than 18. It was also necessary for patient’s to have a stable therapeutic paracentesis frequency for at least 3 months.
Exclusion criteria
Exclusion criteria were: acute coronary syndrome within the past 6 months of enrolment or ongoing angina, prior intolerance to terlipressin, spontaneous bacterial peritonitis in the last 1 month, hepatic vein thrombosis or acute portal vein thrombosis, change in the dose of diuretics within the 30 days preceding the study or anemia with a hemoglobin below 70 mg/dl. The study was approved by the local Human Research Ethics Committee (HREC) and all patients provided written informed consent to participate.
Outcome results
None listed