P-cresol: Correlation With Glomerular Filtration Rate and Outcome in Chronic Kidney Disease
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Purpose
End-stage renal disease is a global epidemia with an estimated incidence of 7% per year and high morbidity-mortality rate. Early detection of chronic kidney disease (CKD) and intervention for CKD complication is important to retard renal progression. However, "traditional uremic toxin" or "small water-soluble molecules" are poorly correlated with the renal function, uremic symptoms and outcomes of CKD patients.
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.
| Condition | Intervention |
|---|---|
|
Risk Factors Renal Progression Death |
Other: there are no interventions currently listed for this study |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- end stage renal disease, reduction of eGFR by 50% and death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Serum level of p-cresol and indoxyl sulfate
| Enrollment: | 300 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
2
CKD patients with normal p-cresol
|
Other: there are no interventions currently listed for this study |
|
3
CKD patient with normal indoxyl sulfate
|
Other: there are no interventions currently listed for this study |
|
4
CKD patients with high indoxyl sulfate
|
Other: there are no interventions currently listed for this study |
|
1
CKD patients with high p cresol
|
Other: there are no interventions currently listed for this study |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
All CKD patients attended at out-patient department of nephrology were included for analysis. The inclusion criteria were adults aged > 18 y/o or < 80 y/o; estimated GFR or CCR < 60 ml/min; no spontaneous renal improvement or progression in past 3 months.
Inclusion Criteria:
- All CKD patients attended at out-patient department of nephrology were included for analysis.
- The inclusion criteria were adults aged > 18 y/o or < 80 y/o
- Estimated GFR or CCR < 60 ml/min
- No spontaneous renal improvement or progression in past 3 months.
Exclusion Criteria:
- Recent cardiovascular disease (Coronary artery disease, myocardial ischemia, cerebrovascular disease or peripheral artery disease) in past 3 months
- Recent infections requiring admission in past 3 months
- Uncontrolled hypertension
- Serum albumin level < 2.5mg/dL
- Unwilling to participate in the trial.
Contacts and Locations| Taiwan | |
| Department of Nephrology,Chang Gung Memorial Hospital | |
| Keelung, Taiwan, 204 | |
| Principal Investigator: | Iwen Wu, MD | Chang Gung Memorial Hospital |
More Information
Publications:
| Responsible Party: | iwenwu, Attending physician, Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00888030 History of Changes |
| Other Study ID Numbers: | IWW-0003 |
| Study First Received: | April 22, 2009 |
| Last Updated: | September 5, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Chang Gung Memorial Hospital:
|
p-cresol indoxyl sulfate chronic kidney disease outcome |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 21, 2013