Chronic Kidney Disease Clinical Trial
Official title:
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.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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