Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to determine whether or not the use of Taurolock (a catheter lock solution) can prevent bacterial peritonitis in patients undergoing peritoneal dialysis.

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Key information

Conditions

Peritonitis Catheter-Related Infections Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Intraabdominal Infections Kidney Diseases Male Urogenital Diseases Peritoneal Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau, Nîmes, Gard, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years or older
Renal insufficiency, stage V (HAS 2007 classification)
Requires incident peritoneal dialysis
No signs of peritoneal infection on inclusion
signed consent
affiliated with a social security system

Exclusion criteria

Patient will have a renal transplant in the upcoming year following dialysis
Survival prognosis for one year is weak
allergy to citrate, (cyclo)-taurolidine, or heparin
patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine
patient has a thrombopenia caused by heparin
impossible to inform the patient correctly
patient under guardianship
patient already included in another biomedical research protocol
no signed consent
no social security system

Treatment and study plan

Taurolock

Device

Placebo

Other

Injectable sodium chloride conditioned in exactly the same manner as the experimental product.

Primary outcomes

Occurence of bacterial peritonitis

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Efficacity of Taurolock in Preventing Primary Bacterial Peritonitis in Patients Undergoing Peritoneal Dialysis for Renal Insufficiency: a Randomized, Multicenter, Double Blind Study With Placebo

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Apr 9, 2010
Registry last updated: Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed