Hemodialysis, Kidney Failure, Chronic, Renal Failure Chronic
Conditions
Brief summary
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.
Detailed description
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.
Interventions
DEVICEBioimpedance spectroscopy (BIS) measurement, SOZO device
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.
Sponsors
California Institute of Renal Research
Frenova Renal Research
ImpediMed Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>=18 years of age; 2. End-stage renal disease with a GFR \<15 mL/min/1.73m\^2 and dialysis dependent requiring 3-times weekly dialysis; 3. Able and willing to remove shoes and stand on SOZO for BIS measurements; 4. Able to provide written informed consent and authorization to use and disclose health information.
Exclusion criteria
1. Is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion; 2. Has a clinical condition that would not allow them to complete the study; 3. Is pregnant or planning to become pregnant; women of childbearing potential (or premenopausal) must be on 2 forms of contraception; 4. Is lactating; 5. Has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator); 6. 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); 7. Patient determined by the attending physician unlikely to be compliant with study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BIS correlation with amount of fluid dialyzed | 12 hemodialysis sessions (over 4 to 6 weeks) | BIS-measured fluid change (volume) will be analyzed for correlation with the volume of fluid removed during hemodialysis as documented on dialysis treatment records. |
Countries
United States
Outcome results
None listed