Observational Study of BIS in Hemodialysis Patients

Study Overview
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Brief Summary
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This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.

Detailed Description
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This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. If changes in BIS parameters correlate with changes in fluid volume and patient symptoms, BIS may help provide a non-invasive way to estimate the amount of fluid to dialyze during a hemodialysis session. Data from this study may be used to inform the design of a future interventional trial of BIS use in hemodialysis patients.

Official Title
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Observational Study of Bioimpedance Spectroscopy (BIS) for Use in a Renal Population

Conditions
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Kidney Failure, Chronic, Renal Failure Chronic, Hemodialysis

Intervention / Treatment
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* Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 years of age; End-stage renal disease with a GFR <15 mL/min/1.73m^2 and dialysis dependent requiring 3-times weekly dialysis; Able and willing to remove shoes and stand on SOZO for BIS measurements; Able to provide written informed consent and authorization to use and disclose health information. Exclusion Criteria: Is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion; Has a clinical condition that would not allow them to complete the study; Is pregnant or planning to become pregnant; women of childbearing potential (or premenopausal) must be on 2 forms of contraception; Is lactating; Has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator); Has an amputation of a limb/s resulting in them being unable to make contact with the SOZO electrodes (amputations of fingers and toes are not an exclusion); Patient determined by the attending physician unlikely to be compliant with study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stable hemodialysis regimen<br>Up to 50 patients on hemodialysis >6 months, with stable target/dry weight, and have not been hospitalized recently | Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device<br>* All patients enrolled in this study will undergo BIS measurement before and after 12 hemodialysis sessions (pre-dialysis and post-dialysis BIS measurements for each session). Measurements are not provided to treating physicians and are not used to guide clinical decisions; i.e., BIS measurements are collected for observational purposes only.<br>|
| Unstable hemodialysis regimen<br>Up to 20 patients who have been on hemodialysis <6 months, or have unintended weight loss/gain, or have recently been hospitalized | Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device<br>* All patients enrolled in this study will undergo BIS measurement before and after 12 hemodialysis sessions (pre-dialysis and post-dialysis BIS measurements for each session). Measurements are not provided to treating physicians and are not used to guide clinical decisions; i.e., BIS measurements are collected for observational purposes only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIS correlation with amount of fluid dialyzed | BIS-measured fluid change (volume) will be analyzed for correlation with the volume of fluid removed during hemodialysis as documented on dialysis treatment records. | 12 hemodialysis sessions (over 4 to 6 weeks) |