Study Stopped
Change of Institutional Affiliation \& Funding
Change of Institutional Affiliation \& Funding
Sponsor study identifier
observational
67
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
February 2013
Actual (reported)February 2013
Actual (reported)March 15, 2013
Actual (reported)March 19, 2013
Actual (reported)Calf bioimpedance measurement
2 dialysis treatments within 1 week
Hemodialysis clinics
Yorkville Dialysis
New York, New York, 10128, United States
Peter Kotanko, MD
Renal Research Institute
67 participants (actual enrollment reported by the registry).
First Submitted
March 15, 2013
First Posted
March 19, 2013
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Structured Nursing Education for Hemodialysis Patients
Contact the study team to confirm eligibility.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)Last Updated
February 24, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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