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临床试验/NCT00888030
NCT00888030已完成不适用

P-cresol: Correlation With Glomerular Filtration Rate and Outcome in Chronic Kidney Disease

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
end stage renal disease, reduction of eGFR by 50% and death

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

end stage renal disease, reduction of eGFR by 50% and death

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

iwenwu

Attending physician

Chang Gung Memorial Hospital

研究点 (1)

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