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| Name | Class |
|---|---|
| California Institute of Renal Research | OTHER |
| Frenova Renal Research | OTHER |
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This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stable hemodialysis regimen | Up to 50 patients on hemodialysis >6 months, with stable target/dry weight, and have not been hospitalized recently |
| |
| Unstable hemodialysis regimen | Up to 20 patients who have been on hemodialysis <6 months, or have unintended weight loss/gain, or have recently been hospitalized |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioimpedance spectroscopy (BIS) measurement, SOZO device | 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (aged 18+ years) with end-stage renal disease, are known to a study investigator, and undergo hemodialysis 3-times per week at an outpatient dialysis unit.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Boiskin, MD | Balboa Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balboa Research - Kearny Mesa | San Diego | California | 92111 | United States | ||
| Balboa Research - Rancho Bernardo |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| San Diego |
| California |
| 92127 |
| United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |