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临床试验/NCT01814254
NCT01814254终止不适用

Comparison of Body Hydration State in Hemodialysis Patients With the Hydra 4200 and ZOE (100 and 5 kHZ) Bioimpedance Devices

Renal Research Institute1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
67
试验地点
1
主要终点
Calf bioimpedance measurement

研究概览

简要总结

Estimation of hydration state in dialysis patients is a major challenge in clinical practice. Although many methods have been studied, none have been established yet for clinical routine practice.

The investigators have developed a method, using segmental and calf bioimpedance spectroscopy (cBIS) techniques to measure body hydration. The device we used based on the FDA-approved Hydra 4200 (Xitron Technologies, San Diego, CA). The Hydra 4200 was initially developed to measure whole body and segmental body fluid volumes but Hydra is approved only for measuring healthy subjects. The cBIS monitors hydration state by continuously measuring change in resistance and resistivity in the calf during hemodialysis (HD) or it can be used for simple measurement before, during and after dialysis. Preliminary results in clinical studies have shown that optimal hydration state of HD patients may be determined by the calf method. This study aims to compare the Hydra 4200 to two other devices: the FDA approved ZOE (100 kHz) Fluid Status Monitor (Noninvasive Medical Technologies, Inc, Las Vegas) and a modified version ZOE 5 kHz. The modified ZOE monitor (ZOE (5 kHz)) delivers frequency of 5 kHz and 0.8 mA current instead of 100 kHz and 2 mA.

The subjects of this study include a group of hemodialysis patients and a group of healthy controls. The healthy controls are used to identify a normal range within the healthy population for each method. Each hemodialysis patient will be studied twice in different hydration state. The study will not change the procedure of the patient's dialysis treatment. Since all devices are based on noninvasive bioimpedance technique, this study has minimal risk.

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

  • Clinically stable

排除标准

  • Implants including pacemakers, implantable pumps, artificial joints
  • Limb amputations
  • Pregnancy
  • Simultaneous participation in another clinical study except observational trials.

结局指标

主要结局

Calf bioimpedance measurement

时间窗: 2 dialysis treatments within 1 week

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)

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