The Effect of Antimicrobial Therapy on the Serum Level of P-cresol in Peritoneal Dialysis Patients

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00433342
First received: February 7, 2007
Last updated: September 14, 2011
Last verified: September 2011

February 7, 2007
September 14, 2011
March 2006
December 2014   (final data collection date for primary outcome measure)
p-cresol reduction rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
p-cresol reduction rate
Complete list of historical versions of study NCT00433342 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Antimicrobial Therapy on the Serum Level of P-cresol in Peritoneal Dialysis Patients
Study on the Effect of Flucloxacillin on the Serum Level of P-cresol in Peritoneal Dialysis Patients

An important subgroup of protein-bound toxins are generated as a result of protein fermentation in the colon. P-cresol is a fermentation metabolite of tyrosine. In renal failure, the colonic generation rate of p-cresol is markedly elevated. After absorption, the majority of p-cresol is conjugated to form p-cresyl sulphate. There is clear evidence, both in vitro and in vivo, that accumulation of conjugated fermentation metabolites is correlated with clinical important endpoints. Free p-cresol is an independent predictor for mortality in hemodialysis patients.

Moreover, in renal failure patients, neither hemodialysis nor peritoneal dialysis is capable of normalising the clearly elevated serum concentrations of p-cresyl sulphate. Removal is at least partially diminished by the important protein binding of p-cresol. Besides adaptation of renal replacement therapies to improve removal of protein bound solutes, another approach is to lower the generation of uremic toxins.

The mechanisms underlying colonic carbohydrate and protein fermentation, responsible for the generation of p-cresol, are only partially understood. On the one hand, the ratio of fermentable carbohydrates to proteins has been shown to be an important determinant of protein fermentation. On the other hand, changes in the colonic bacterial flora influence the generation of p-cresol in dogs and in healthy human individuals.

The effect of antibiotic therapy on bacterial protein fermentation and thus on the generation of p-cresol is not known. A reanalysis of data abstracted from a recent longitudinal study in peritoneal dialysis (PD) patients suggests that antibiotic therapy may lower p-cresol levels substantially. The current study aims at confirming these data in a prospective manner.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Kidney Disease
Drug: Flucloxacillin
500 mg QD oral
Other Name: Floxapen
  • Experimental: I
    Flucloxacillin
    Intervention: Drug: Flucloxacillin
  • No Intervention: II
Bammens B, Evenepoel P, Keuleers H, Verbeke K, Vanrenterghem Y. Free serum concentrations of the protein-bound retention solute p-cresol predict mortality in hemodialysis patients. Kidney Int. 2006 Mar;69(6):1081-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
10
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18
  • Exit site infection, requiring antibiotic treatment
  • Maintenance therapy with peritoneal dialysis

Exclusion Criteria:

  • Signs of peritonitis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00433342
ML3532
No
Björn Meijers, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Study Chair: Björn Meijers, MD UZ Leuven
Study Director: Pieter Evenepoel, MD, PhD UZ Leuven
Universitaire Ziekenhuizen Leuven
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP