Chronic Kidney Disease Clinical Trial
Official title:
Evaluation of Body Hydration Status in Hemodialysis Patients Using Segmental Bioimpedance Analysis
Verified date | February 2016 |
Source | Renal Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 89 |
Est. completion date | February 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Renal Research Institute |
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dry weight as determined by segmental bioimpedance in comparison to baseline | 1 month | No | |
Secondary | Mean pre dialysis and post dialysis blood pressure in comparison to baseline | 1 month | No | |
Secondary | Numbers and doses of blood pressure medications prescribed | 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 | No |
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