Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441623
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2007-02-28
Brief Title:
The Role of P-cresol and Related Protein Fermentation Metabolites in Chronic Kidney Disease Patients
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
A Single Centre Observational Cohort Study on the Prognostic Relevance of P-cresol and Related Uremic Retention Solutes in the Development andor Progression of Renal Failure and Cardiovascular Disease in Chronic Kidney Disease Patients
Status:
COMPLETED
Status Verified Date:
2016-05
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:
Study on the natural history of uremic retention solutes in patients with mild-to-moderate chronic kidney disease
Detailed Description:
Protein-bound uremic retention solutes are increasingly recognized to play a role in the pathophysiology of the uremic syndrome Numerous in vitro findings are indicative for their implication in the biochemical and physiological changes of uremia Several of these protein-bound retention solutes originate from bacterial protein fermentation in the colon p-cresyl sulfate a fermentation metabolite of the amino acid tyrosine is considered a prototype of this group of uremic solutes The protein binding of this molecule was shown to be about 90 in end-stage renal disease patients Several data have suggested that p-cresol plays a role in the immunodeficiency of uremia Recently a link between the molecule and endothelial dysfunction has been demonstrated Also other members of the class of protein-bound solutes have been found to be associated with immune dysfunction endothelial cell dysfunction and closely related to the latter oxidative stress
Free serum levels of p-cresol were shown to be greater in stage 5 chronic kidney disease CKD patients treated with hemodialysis HD hospitalized for infectious disease Furthermore a positive relationship was found between serum total p-cresol level and a uremic symptom score in patients treated with peritoneal dialysis PD whereas a correlation with small water-soluble solutes and the middle molecule β2-microglobulin was absent A recent prospective observational study in stage 5 CKD patients treated with conventional HD 3 x 4 hours per week indicated that the accumulation of p-cresol is a risk factor for overall mortality
Data on the serum concentrations of p-cresol in chronic kidney disease patients are lacking The investigators hypothesise that the serum concentration of p-cresol is an independent predictor of progression to end stage renal disease and is an independent predictor for cardiovascular disease
Free serum levels of p-cresol were shown to be greater in stage 5 chronic kidney disease CKD patients treated with hemodialysis HD hospitalized for infectious disease Furthermore a positive relationship was found between serum total p-cresol level and a uremic symptom score in patients treated with peritoneal dialysis PD whereas a correlation with small water-soluble solutes and the middle molecule β2-microglobulin was absent A recent prospective observational study in stage 5 CKD patients treated with conventional HD 3 x 4 hours per week indicated that the accumulation of p-cresol is a risk factor for overall mortality
Data on the serum concentrations of p-cresol in chronic kidney disease patients are lacking The investigators hypothesise that the serum concentration of p-cresol is an independent predictor of progression to end stage renal disease and is an independent predictor for cardiovascular disease
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