P-cresol: Correlation With Glomerular Filtration Rate and Outcome in Chronic Kidney Disease
NCT ID: NCT00888030
Last Updated: 2012-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2006-05-31
2011-12-31
Brief Summary
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Putative protein-bound solute, p-cresol, is accumulated in ESRD patients receiving dialysis therapy. This uremic solute was associated with endothelial dysfunction, immune dysregulation and can predict outcome in hemodialysis patient. P-cresol inhibits endothelial cell proliferation and endothelial response to inflammatory cytokines. In vitro, p-cresol decreases leukocyte transendotherliar migratory function and inhibit production of phagocyte reactive species. Clinically, p-cresol plays a pathophysiological role in the uremic toxicity. High free serum level of p-cresol is associated with mortality in hemodialysis patients.
Information of p-cresol in CKD patients is not available. The investigators hypothesized p-cresol can be accumulated in early CKD and have a positive correlation with the morbidity- mortality of CKD patients.
Value of p-cresol in different stages of CRF is still unknown. Information of p-cresol in CKD patients is not available. The investigators hypothesized p-cresol can be accumulated in early CKD and have a positive correlation with the morbidity- mortality of CKD patients.
The principal aim of this prospective cohort study is to investigate the association between total serum levels of p-cresol and the glomerular filtration rate. The correlation of level of p-cresol and morbidity-mortality in CKD patients will be also evaluated.
To determine the relationship, patients of nephrology clinic with a diagnosis of CKD were enrolled in this prospective study and follow-up for 1-year period. The association between total and free serum levels of p-cresol and the glomerular filtration rate were evaluated in CKD patients. The p-cresol level was correlated with other many inflammatory markers (white blood cell counts, ferritin, hs-crp, leptin) and also with the hospitalization rate secondary to cardiovascular and infectious event. The renal outcome and all-cause mortality was assessed. Determination of this relationship can help to establish an accurate marker for early detection of CKD and also its prognostic role in CKD patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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2
CKD patients with normal p-cresol
there are no interventions currently listed for this study
3
CKD patient with normal indoxyl sulfate
there are no interventions currently listed for this study
4
CKD patients with high indoxyl sulfate
there are no interventions currently listed for this study
1
CKD patients with high p cresol
there are no interventions currently listed for this study
Interventions
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there are no interventions currently listed for this study
Eligibility Criteria
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Inclusion Criteria
* Estimated GFR or CCR \< 60 ml/min
* No spontaneous renal improvement or progression in past 3 months.
Exclusion Criteria
* Recent infections requiring admission in past 3 months
* Uncontrolled hypertension
* Serum albumin level \< 2.5mg/dL
* Unwilling to participate in the trial.
18 Years
80 Years
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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iwenwu
Attending physician
Principal Investigators
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Iwen Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Department of Nephrology,Chang Gung Memorial Hospital
Keelung, , Taiwan
Countries
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References
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Meijers BK, Bammens B, De Moor B, Verbeke K, Vanrenterghem Y, Evenepoel P. Free p-cresol is associated with cardiovascular disease in hemodialysis patients. Kidney Int. 2008 May;73(10):1174-80. doi: 10.1038/ki.2008.31. Epub 2008 Feb 27.
Atoh K, Itoh H, Haneda M. Serum indoxyl sulfate levels in patients with diabetic nephropathy: relation to renal function. Diabetes Res Clin Pract. 2009 Feb;83(2):220-6. doi: 10.1016/j.diabres.2008.09.053. Epub 2008 Nov 22.
Meijers BK, de Loor H, Verbeke K, Evenepoel P. p-Cresol for better or worse: but what are we measuring? Kidney Int. 2006 Jul;70(1):232; author reply 232-3. doi: 10.1038/sj.ki.5001530. No abstract available.
Other Identifiers
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IWW-0003
Identifier Type: -
Identifier Source: org_study_id