drugset / Trial / NCT03027635

PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis

NCT03027635

Terminated 13 enrolled Nina Kimer
RandomizedParallel-groupOpen-labelSupportive care

Summary

Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small volume fluid drainage at home. The treatment may improve the management of ascites and have a beneficial effect on the quality of life. This study aims to evaluate the beneficial and harmful effects of the peritoneal catheter (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic resistant ascites. The trial is an investigator initiated, randomised, single blind, parallel arm, controlled trial. Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will receive ciprofloxacin to prevent spontaneous bacterial peritonitis. We will include 32 adult patients with cirrhosis Duration of trial 18 months. The total duration of follow up is six months. The primary outcome is paracentesis free survival.

Timeline

Start
2017-01-20
Primary completion
2019-05-15
Completion
2019-05-15

Drugs

EvaluationDrugModalityDoseRoute
Background Ciprofloxacin Small molecule 500 mg

Indications