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临床试验/NCT00576524
NCT00576524终止2 期

Application of Impedance Threshold Device Technologies to Treat and Prevent Intradialytic Hypotension in Children Undergoing Hemodialysis

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
2
试验地点
2
主要终点
Fluid Removal

研究概览

简要总结

The purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.

详细描述

Effective fluid removal during hemodialysis is one of the biggest challenges in children with end-stage renal disease (ESRD). Generally, children do not tolerate having more than 3-4% of their body weight removed during each dialysis session thus necessitating multiple sessions each week to ensure effective renal replacement. Excessive fluid removal is often associated with nausea, vomiting, hypotension and cramps resulting in serious complications in patient care during and immediately after dialysis as well as reduced patient compliance. The development of novel therapies to increase the amount of fluid removed during each session without a corresponding increase in the incidence of complications is therefore very important to improve quality and compliance with hemodialysis; and eventually survival of children with ESRD. The purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Subjects 8-18 years of age
  • Subjects undergoing hemodialysis for ESRD

排除标准

  • Subjects less than 8 years old or greater than 18 years old.
  • Hemodialysis for indications other than ESRD.
  • Current symptoms of chest pain, shortness of breath, fever, presence of dilated cardiomyopathy, unstable congestive heart failure, pulmonary hypertension, atrial fibrillation, hyperthyroidism, and aortic stenosis.

结局指标

主要结局

Fluid Removal

时间窗: 6 weeks

Fluid removed as percentage of dry body weight.

次要结局

  • Extra Days to Achieve Target Dry Weight(6 weeks)
  • Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.(6 weeks)

研究者

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

Vijay Srinivasan

Attending Physician

Children's Hospital of Philadelphia

研究点 (2)

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