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临床试验/NCT04227158
NCT04227158已完成不适用

The Association Between the Distributions MCH and RBC, and Mortality in a Cohort of Chronic Hemodialysis Patients: a 3-year Retrospective Observational Study

University of Hyogo1 个研究点 分布在 1 个国家目标入组 437 人开始时间: 2020年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
437
试验地点
1
主要终点
Survival rate between high or low RBC group (all cause death)

研究概览

简要总结

Patients were classified into two groups based on the values of MCH and RBC, patients with MCH ≥30 pg but <35 pg and RBC ≤350×104/μL; and MCH <30 pg and RBC >350×104/μL. Associations between all-cause mortality and the distributions of MCH and RBC were assessed by Kaplan-Meier curves and Cox proportional hazards regression model.

详细描述

The Hb levels generally provides the value of RBC and iron status because mean corpuscular hemoglobin MCH is derived from the Hb divided by RBC. MCH depends on the size and concentration of erythrocytes. Thus, the value of RBC and MCH depend on dose of ESA and iron, respectively. Guidelines for Renal Anemia in Chronic Kidney Disease of 2015 Japanese Society for Dialysis Therapy recommend administration hemoglobin (Hb) levels ≥10 g/dL but <12 g/dL in dialysis patients.Patients whose Hb levels is maintained at 10 to 12 g/dL, Hb levels is widely distributed when divided into RBC and MCH. Therefore, the investigators examined the prognosis of life in the distribution of MCH and RBC.

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
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will be controlled with hemoglobin levels between ≥10 g/dL and <12 g/dL and had undergone maintenance HD for >1 year.

排除标准

  • Patients will be excluded if they have peritoneal dialysis combined with HD, do not have records of laboratory investigations during this period, or are transferred to another hospital or lost to follow-up.

结局指标

主要结局

Survival rate between high or low RBC group (all cause death)

时间窗: three years (retrospectively)

Survival curves for 3-year survival, based on all available follow-up data, will perform with the use of Kaplan-Meier estimates and will be compared between groups with the use of the log-rank test, and used Holm's method as post hoc.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yoshihiro Tsuji

visiting researche, Yoshihiro Tsuji

University of Hyogo

研究点 (1)

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