ESRD (End Stage Renal Disease)
Conditions
Brief summary
The pilot clinical study will assess the correlation between fluid removal during dialysis and HemoCept device data.
Interventions
None listed
Sponsors
HemoCept Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject or representatives must have voluntarily signed the informed consent form before any study related procedures * Subjects can be any gender, but must be between (and including) 18 and 75 years of age * Subject has been on dialysis for more than 90 days and has been diagnosed with end stage kidney disease * Subject is able and willing to provide informed consent and HIPAA authorization. * Subject is able and willing to meet all study requirements * Subject is able to place electrodes on bilateral deltoids and above the pant line on the waist.
Exclusion criteria
* Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study. * Subject has a personal medical history that includes: Long Q-T syndrome, Cardiac channelopathies, genetic heart defects, Seizures, Acute untreated blood clotting disorders or acute untreated bleeding disorders * Subject has had a heart transplant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between dry weight changes and HemoCept device measurements. | Before and after one dialysis session, over the course of 1 day | The primary analysis will be conducted using HemoCept device readings taken before dialysis and at the end of dialysis, just prior to return of blood and fluid from the machine. The device data will then be assessed for its comparison to dry weight changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device related adverse events, and the possible correlation of skin tone to device results. | Before and after 1 dialysis session, over the course of 1 day. | -Device-related adverse events: device-related adverse events included all adverse eventsclassified as definitely, probably, possibly, or undetermined relation to the device or procedure --Exploratory correlation of skin tone and device performance: Monk Skin Tone data will be collected to explore potential correlation between subject skin tone and HemoCept device readings. |
Countries
United States
Outcome results
None listed