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Body Fluid Dynamics in Hemodialysis Patients, an Estimation of Dry Weight

2016年2月22日 更新者:Renal Research Institute

Evaluation of Body Hydration Status in Hemodialysis Patients Using Segmental Bioimpedance Analysis

The purpose of this study is to learn how the amount of fluid in the body of a hemodialysis patient affects him or her. Body hydration is the amount of fluid in the human body and known to be related to blood pressure. Too much fluid can lead to high blood pressure which can cause heart problems and eventually lead to death. Bioimpedance Spectroscopy (BIS) is a method that may be used to measure body hydration. This can be applied in the whole body, arm, trunk, calf, and leg. It is a non-invasive and inexpensive method and no known risk. BIS measurements can be used to assess optimal hydration status which is defined as a patient's ideal weight after completing a dialysis treatment. The investigators hypothesize that your target weight may be better estimated by the BIS. The results of this study, in particular the continuous measurement of calf hydration which is associated with the hydration of the whole body, may provide useful information about physiologic ("healthy") body hydration. It may possibly help to improve treatment procedures for patients in the future. The Renal Research Institute plans to enroll 100 chronic hemodialysis patients and 200 healthy controls in this study.

研究概览

地位

终止

条件

详细说明

Estimation of the hydration state of chronic kidney disease (CKD) patients is an important aspect of clinical practice. Deterioration in renal function often leads to volume overload with resulting hypertension and there is no simple and accurate technique available to measure body hydration at the moment.

In hemodialysis (HD) patients, one limitation to adequate ultrafiltration necessary to achieve optimal hydration status (dry weight) is inadequate vascular refilling from the interstitial space. Blood pressure may decrease due to limitation of vascular refilling even when dry weight is far from being achieved. Therefore, an objective and accurate method to provide hydration state would be very useful for clinical practice. Whole body bioimpedance techniques have been used to measure body fluid volume for many years. However, it is difficult to accurately indicate the hydration state by body fluid volume of normal variations, and the accuracy of measurement is influenced by various body compositions. Recently, the investigators have proposed that hydration can be approached using a calf bioimpedance technique by monitoring change in resistance during HD. Since the lower limbs tend to contain more fluid than other body segments in ambulatory people due to the effect of gravity, measurement of the calf provides more accurate information about body hydration in the HD patient.

In this study, the investigators hypothesize that:

  1. Since the degree of hydration is greater in the leg than in the arm and the trunk due to the effect of gravity, monitoring change in resistance in the whole or part of the leg will provide information as to whether optimal hydration status (a state in which excess extracellular fluid is absent) has been attained. The investigators postulate that a change in the slope of resistance curve (CSR) in the calf approaches zero as optimal hydration status is achieved.
  2. Optimal hydration status can be approximated by comparison of two values: (1) measurement of local electrical resistivity in the interstitial compartment and (2) known range of resistivity in healthy subjects (HS). Combination of the normalized resistivity (μ) and CSR are considered as indicators of physiological optimal hydration status. Physiological optimal hydration status, as an objective index, is a major goal of hemodialysis so that the excess body water can be maximally removed according to this value. In practice this can be approached but should never be exceeded.

Because flattening of the curve should be verified by the near normal resistivity, a group of healthy subjects would have to be added to provide a normal range of resistivity at all ages and both sexes.

研究类型

观察性的

注册 (实际的)

89

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Stable hemodialysis patients believed to be at all levels of hydration by their treating physician will be chosen. 100 subjects will be chosen to include approximately 50% women in the hemodialysis program. Subjects will be selected from a wide range of ages and body mass indexes

描述

Inclusion Criteria:

  • Stable hemodialysis patients believed to be at all levels of hydration by their treating physician should be chosen.

Exclusion Criteria:

  • Myocardial infarction or stroke in the preceding 6 months
  • Two episodes of hypotension (systolic BP < 90 mmHg) during the 3 dialysis procedures preceding entering the treatment phase
  • Grade IV CHF by NY classification
  • Simultaneous participation in another clinical study except observational trials.
  • Any psychological condition which could interfere with the patient's ability to comply with the study protocol.
  • Pregnancy.
  • Amputation of a limb.
  • Pace maker, implantable pump, artificial joint.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:预期

队列和干预

团体/队列
Hemodialysis patients
Dialysis patients will have their estimated dry weight measured with calf segmental bioimpedance. Based on these measurements, their dry weight will be adjusted and the amount of fluid removed during subsequent dialysis treatments will be increased by 200-300mL. The additional fluid removal will occur during 3 consecutive hemodialysis sessions. In addition, these subjects will also use VStim during these treatments. to prevent common intradialytic symptoms by promoting vascular refilling.
Healthy Controls
No Intervention was administered. Both groups had their hydration status measured with segmental bioimpedance The group of healthy subjects was studied in order to obtain a range of values for normal hydration status.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Dry weight as determined by segmental bioimpedance in comparison to baseline
大体时间:1 month
1 month

次要结果测量

结果测量
措施说明
大体时间
Mean pre dialysis and post dialysis blood pressure in comparison to baseline
大体时间:1 month
1 month
Numbers and doses of blood pressure medications prescribed
大体时间:1 month
If the blood pressure is improved based on better assessment of dry weight, the need for multiple blood pressure meds and dosing will be reduced.
1 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Fansan Zhu, MD、Renal Research Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年4月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2015年2月1日

研究注册日期

首次提交

2014年12月16日

首先提交符合 QC 标准的

2014年12月19日

首次发布 (估计)

2014年12月25日

研究记录更新

最后更新发布 (估计)

2016年2月24日

上次提交的符合 QC 标准的更新

2016年2月22日

最后验证

2016年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • RRI091-97

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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