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Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01101087
Enrollment
150
Registered
2010-04-09
Start date
2010-07-31
Completion date
2015-12-31
Last updated
2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-related Infections, Peritonitis, Renal Insufficiency

Keywords

Dialysis

Brief summary

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.

Interventions

DEVICETaurolock
OTHERPlacebo

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Occurence of bacterial peritonitis24 months

Countries

France, French Polynesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026