ESRD (End Stage Renal Disease)
Conditions
Brief summary
The goal of this clinical pilot study is to evaluate the ability of the device to properly detect the hydration status of the subject through the study of fluid removal data 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
* Study 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 willing and able 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 HemoCept device and changes in dry weight. | At specified points during dialysis treatment for 9 dialysis sessions, over the course of 3 weeks. | The primary end point will be to determine if there is a correlation between HemoCept device data and dry weight changes during dialysis. The primary analysis will be conducted at specific points during dialysis treatment: prior to dialysis, in the middle of the dialysis session, and immediately following the completion of dialysis treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-related adverse events: device-related adverse events included all adverse events classified as definitely, probably, possibly, or undetermined relation to the device or procedure | From enrollment until the completion of 9 dialysis sessions, over a period of 3 weeks. | All secondary endpoints will be summarized descriptively, and no hypothesis tests are planned. |
Countries
United States
Outcome results
None listed