CompletedPhase 2ACTRN12616000321448

Outpatient Terlipressin Infusion for the Treatment of Refractory Ascites.


Sponsor

Paul Gow

Enrollment

5 participants

Start Date

Jul 14, 2015

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

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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 s

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.


Locations(1)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

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ACTRN12616000321448


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