跳至主要内容
临床试验/NCT04612595
NCT04612595Unknown不适用

The Association Between Serum Urea Nitrogen to Creatinine Ratio and the Survival in Patients With DKD

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
increasing by 50% of the serum creatinine level from baseline

研究概览

简要总结

Research Objective: To evaluate the prognostic value of serum urea nitrogen to creatinine ratio (sUCR) in the progression of DKD.

Research Design: This study was designed as a multicenter, retrospective cohort study. According to sex and CKD stage , patients are divided into four groups,then evaluate the prognostic value of mean sUCR and ΔsUCR (fluctuation of sUCR over time, meaning monthly rate of change) in the progression of DKD.

详细描述

Object and source: Patients diagnosed with DKD who meet the inclusion criteria are enrolled into the study.

Observation index: At baseline and every medical visit, therapeutic relevant information was collected. Data mainly include demographic characteristics(age, gender, place of residence, marriage, education degree), lifestyles(smoking, drinking, exercise), clinical characteristics(body mass index, blood pressure, duration , history of CVD, complications, nutrition situation), laboratory indexes (serum creatinine, blood urea nitrogen, glycosylated hemoglobin, urinary albumin to creatinine ratio, 24-hour urinary albumin, 24-hour urine urea nitrogen, etc.).

Quality assurance plan: The present study should be performed according to the principles of the Declaration of Helsinki and has been approved by the Ethics Committee of Guangdong Provincial People's Hospital.

Plan for missing data: When the participants drop out, the researcher should contact the participants by phone, email, text message, letter etc. and ask the reason, making record as full as possible.

Statistical analysis plan: Data are presented as mean±SD for continuous variables and as a number(percentage) for categorical variables. According to sex and CKD stage , patients are divided into four groups,then evaluate the prognostic value of mean sUCR and ΔsUCR (fluctuation of sUCR over time, meaning monthly rate of change) in the progression of DKD. The relationship between baseline characteristics among the four groups was compared by using one-way analysis of variance test, Kruskal-Wallis test or Chi-squared test where appropriate. Survival rates are estimated using Kaplan-Meier analysis, and the significance of differences was analyzed using the log-rank test. Cox proportional hazard regression analysis is used to assess the association between the clinical outcomes and mean sUCR and ΔsUCR. In multivariate analysis, we enter variables using a P value of <0.10 as the selection criterion or considered clinically significant. Hazard ratios (HRs) are presented with 95% CIs. All statistical analysis was performed with the use of SPSS (version 19.0, SPSS, Chicago, USA) and Prism 7.0 (GraphPad Software, San Diego, CA, USA). A two-tailed P value <0.05 was considered to be statistically significant.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

increasing by 50% of the serum creatinine level from baseline

时间窗: 10 years

increasing by 50% of the serum creatinine level from baseline

a composite of end-stage kidney disease

时间窗: 10 years

dialysis, transplantation, or a sustained estimated GFR of \<15 ml per minute per 1.73 m2

all-cause death

时间窗: 10 years

according to the criteria of death

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验