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Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Catheter-related Infections
Peritonitis
Renal Insufficiency

Treatments

Other: Placebo
Device: Taurolock

Study type

Interventional

Funder types

Other

Identifiers

NCT01101087
2009-A00599-48 (Other Identifier)
PHRC-N/2009/BB

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups, including a placebo group

Taurolock
Experimental group
Treatment:
Device: Taurolock
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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