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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00433342
Recruitment Status : Suspended
First Posted : February 9, 2007
Last Update Posted : September 15, 2011
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven

February 7, 2007
February 9, 2007
September 15, 2011
March 2006
December 2014   (Final data collection date for primary outcome measure)
p-cresol reduction rate [ Time Frame: 8 weeks ]
p-cresol reduction rate
Complete list of historical versions of study NCT00433342 on Archive Site
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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.

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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Kidney Disease
Drug: Flucloxacillin
500 mg QD oral
Other Name: Floxapen
  • Experimental: I
    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 Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Björn Meijers, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
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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