MedTrace Logo

PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis

NCT03027635 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-05-20

No results posted yet for this study

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.

Conditions

  • Cirrhosis
  • Ascites Hepatic
  • Ascites (Non-Malignant)

Interventions

DEVICE

PleurX, peritoneal tunnelated catheter

A permanent catheter

DEVICE

Large Volume Paracentesis

Short time drainage

DRUG

Ciprofloxacin 500Mg Tablet

SBP prophylaxis

Sponsors & Collaborators

  • Nina Kimer

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03027635 on ClinicalTrials.gov