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临床试验/NCT01103167
NCT01103167Unknown4 期

The Association Between Body Composition and Biomarkers in Hemodialysis Patients

Gachon University Gil Medical Center2 个研究点 分布在 2 个国家目标入组 160 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
4 期
入组人数
160
试验地点
2
主要终点
blood pressure

研究概览

简要总结

Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical management for maintaining normovolemia is needed.

The investigators hypothesized that intervention of volume status with the body composition monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.

详细描述

The investigators will assess BCM in enrolled hemodialysis patients by 4 weeks for 16 weeks During the former 8-week intervention period, The investigators will adjust patients' volume status according to the results of BCM.

During the latter 8-week observational period, The investigators will evaluate the changes of patients' hemodynamic parameters and biomarkers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • 6-month or more stable hemodialysis patients
  • 18 years or more
  • less than 5% of changes of dry weight for last 3 months

排除标准

  • pregnancy
  • active malignancy
  • cardiac pacemaker or defibrillator
  • history of extremity amputation
  • active infectious disease within 3 months
  • admission history for complication related to hemodialysis within 3 months

结局指标

主要结局

blood pressure

时间窗: up to 16 weeks

Systolic blood pressure, number of anti-hypertensive agents hypotensive episode

次要结局

  • biomarkers(up to 16 weeks)

研究者

申办方类型
Other

研究点 (2)

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