PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis

NCT03027635 | Terminated DMC

• 1 other identifier: PETRA21042016
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

diuretic resistant ascites; Paracentesis; PleurX; Peritoneal tunnelated catheter

Outcome Measures

Primary Outcomes (1)

• Time to first paracentesis

  18 months

Secondary Outcomes (4)

• Adverse events

  18 months

• Nutritional Status

  18 months

• Renal function

  18 months

• Cardiac Output

  18 months

Study Arms (2)

PleurX

EXPERIMENTAL

The PleurX catheter is a tunnelated peritoneal catheter, designed for permanent placement in the peritoneal cavity. The catheter is placed by a physician under sterile conditions. Drainage of ascites is done using vacuum bottles connected to the catheter. This can be managed by a home nurse or the patient.

Device: PleurX, peritoneal tunnelated catheter; Drug: Ciprofloxacin 500Mg Tablet

Large Volume Paracentesis

ACTIVE COMPARATOR

Large volume paracentesis is performed in sterile technique, a small incision is made through the skin, and a catheter is inserted through muscle and peritoneum. After the procedure, the patient remains in hospital for observation until the fluid is drained.

Device: Large Volume Paracentesis; Drug: Ciprofloxacin 500Mg Tablet

Interventions

PleurX, peritoneal tunnelated catheter DEVICE

A permanent catheter

PleurX

Large Volume Paracentesis DEVICE

Short time drainage

Large Volume Paracentesis

Ciprofloxacin 500Mg Tablet DRUG

SBP prophylaxis

Large Volume Paracentesis; PleurX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis of any aetiology
• Diuretic resistant ascites defined as i) an inability to mobilise ascites (minimal or no weight loss) despite administration with the maximum tolerable doses of oral diuretics or a daily dose of spironolactone 400 mg and re-accumulation of fluid after therapeutic paracentesis within two weeks or ii) diuretic-related complications including (but not limited to) azotemia, hepatic encephalopathy, or progressive electrolyte imbalances
• Able to read and understand Danish
• Signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study
• Male or female of any age
• Age at least 18 years
• Expected survival at least three months.

You may not qualify if:

• Participants eligible and listed for TIPS
• Serum creatinine levels above 135 umol/L
• Overt hepatic encephalopathy in the two weeks before randomization
• Ascites due to other causes than cirrhosis such as: malignant disease, congestive heart failure, end-stage renal disease, pancreatitis, or Budd-Chiari (hepatic vein thrombosis), or chylous ascites
• Ongoing intra-abdominal infection (peritonitis) or active systemic or local infections, such as urinary tract infection or pneumonia
• Participation in a clinical study that may interfere with participation in this study;
• Evidence of extensive ascites loculation
• Coagulopathy
• Variceal bleeding within two weeks before randomisation
• Intraabdominal surgery within four months before randomisation
• Spontaneous bacterial peritonitis (neutrophil count\>250/µl within 24 hours of randomization)
• Patients with an increased risk of procedure related complications as judged by the primary healthcare provider

Sponsors & Collaborators

• Nina Kimer: lead

Study Sites (1)

Gastro Unit, medical Division, University Hospital Hvidovre

Hvidovre, Danmark, 2650, Denmark

Location

MeSH Terms

Conditions

Fibrosis; Ascites

Interventions

Ciprofloxacin; Tablets

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: January 23, 2017
• Study Start: January 20, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

DK (1)