Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433342
Status:
TERMINATED
Last Update Posted:
2020-04-27
First Post:
2007-02-07
Brief Title:
The Effect of Antimicrobial Therapy on the Serum Level of P-cresol in Peritoneal Dialysis Patients
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Study on the Effect of Flucloxacillin on the Serum Level of P-cresol in Peritoneal Dialysis Patients
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None