PEriToneal Catheter Versus Repeated Paracentesis for Ascites in Cirrhosis (PETRA)

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ClinicalTrials.gov Identifier: NCT03027635

Recruitment Status : Terminated (Slow recruitment and limited funding. The treatment intervention is instituted in clinical practice as and end-stage treatment option at hospitals in Denmark)

First Posted : January 23, 2017

Last Update Posted : May 20, 2019

Sponsor:

Information provided by (Responsible Party):

Nina Kimer, Copenhagen University Hospital, Hvidovre

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cirrhosis Ascites Hepatic Ascites (Non-Malignant)	Device: PleurX, peritoneal tunnelated catheter Device: Large Volume Paracentesis Drug: Ciprofloxacin 500Mg Tablet	Not Applicable

Detailed Description:

Ten percent of patients with cirrhosis develop ascites. In 90% of patients, ascites can be treated with diuretics. The management of the remaining 10% with diuretic resistant ascites is challenging. Symptoms including abdominal pain, dyspnoea, nausea, vomiting, and anorexia have a detrimental impact on the quality of life. Repeated large volume paracentesis provides only temporary improvement of symptoms.

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.

Investigator initiated, randomised, single blind, parallel arm, controlled trial.

Due to the nature of the intervention and the primary outcome measure, Investigators are unable to conduct the trial with blinding of the patients, the investigators or use blinded outcome assessment.

Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will receive ciprofloxacin to prevent spontaneous bacterial peritonitis.

The study investigators will include 32 adult patients with cirrhosis of any aetiology and diuretic resistant ascites.

Gastrounit, Hvidovre University Hospital, Department of Gastroenterology and Hepatology, Odense University Hospital, Department of Gastroenterology and Hepatology, Aarhus University Hospital, and Centre for Hepatology, UCL Institute for Liver and Digestive Health, Royal Free Campus, University College London, UK 18 months. The total duration of follow up is six months. The primary outcome is paracentesis free survival. Secondary outcomes include cumulative number of paracentesis, cirrhosis-related complications, safety, quality of life, changes in metabolic and nutritional parameters, circulatory dysfunction, renal function, cardiac output, neuro-humoral changes.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	13 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Tunnelated Peritoneal Catheter Versus Repeated Large Volume Paracentesis for Diuretic Resistant Ascites in Patients With Cirrhosis: An Investigator Initiated, Open, Parallel Arm Randomized Controlled Trial
Actual Study Start Date :	January 20, 2017
Actual Primary Completion Date :	May 15, 2019
Actual Study Completion Date :	May 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: North American Indian childhood cirrhosis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: PleurX 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 A permanent catheter Drug: Ciprofloxacin 500Mg Tablet SBP prophylaxis
Active Comparator: Large Volume Paracentesis 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 Short time drainage Drug: Ciprofloxacin 500Mg Tablet SBP prophylaxis

Outcome Measures

Primary Outcome Measures :

Time to first paracentesis [ Time Frame: 18 months ]

Secondary Outcome Measures :

Adverse events [ Time Frame: 18 months ]
Number of AEs in groups
Nutritional Status [ Time Frame: 18 months ]
Indirect calorimetry
Renal function [ Time Frame: 18 months ]
glomerular filtration rate
Cardiac Output [ Time Frame: 18 months ]
cardiac output

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027635

Locations

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Denmark
Gastro Unit, medical Division, University Hospital Hvidovre
Hvidovre, Danmark, Denmark, 2650

Sponsors and Collaborators

Nina Kimer

More Information

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Responsible Party:	Nina Kimer, MD, PhD, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:	NCT03027635
Other Study ID Numbers:	PETRA21042016
First Posted:	January 23, 2017 Key Record Dates
Last Update Posted:	May 20, 2019
Last Verified:	May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	Due to Danish Legislation only anonymized data may be available upon request

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by Nina Kimer, Copenhagen University Hospital, Hvidovre:


diuretic resistant ascites Paracentesis PleurX Peritoneal tunnelated catheter

Additional relevant MeSH terms:

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Liver Cirrhosis Fibrosis Ascites Pathologic Processes Liver Diseases Digestive System Diseases Ciprofloxacin Anti-Bacterial Agents	Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors

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