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| Name | Class |
|---|---|
| Centers for Dialysis Care, Inc | INDUSTRY |
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The purpose of this study is to use the photo-plethysmographic [PPG] waveform signal to guide the dialysis and ultrafiltration [UF] of chronic maintenance hemodialysis patients, and to further the investigators understanding of homeostasis in hemodialysis.
The investigators hypothesize that the signals generated from the PPG device along with traditional monitoring and nursing judgment, will allow experienced, oriented staff to anticipate hemodynamic instability, intervene to prevent or mitigate the intradialytic hypotention [IDH], forestalling the onset of non-facilitating compensatory reflexes that preclude the patient from achieving an appropriate post-dialysis weight consistent with euvolemia. Furthermore, it is hypothesized that the nephrologist and staff will be able to wean patients from anti-hypertensive medications and craft patient specific dialysis orders and UF profiles that achieve consistent, comfortable treatment to appropriate end points.
The study aims include:
Aim 1: To confirm the temporal sequence of PPG signals and changes in BP in routine hemodialysis.
Aim 2: To refine further the predictive algorithms of PPG, augmented with continuous cardiac event monitoring (pre-intra-post hemodialysis) Aim 3: To develop targeted interventions to reverse the cardiovascular stress indicated by the PPG and to maintain perfusion.
Aim 4: To develop care paths approved by the medical staff and primary care nephrologist allowing RNs to respond to signals from the PPG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | All patients will be enrolled in the same intervention arm. Interventions are implemented based in 1-4 event levels on the device. Interventions include: "Place dialysis chair into position 3", "Decrease dialysate temperature", "Decrease ultrafiltration rate by 25%", and "Decrease ultrafiltration rate by 50%". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Place dialysis chair into position 3. | Other | Upon device notification event 1, place patient in dialysis chair position 3. |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference between prescribed dry weight and actual measured weight at end of dialysis session. | Percent difference between prescribed dry weight and actual weight at end of dialysis session. | 8 weeks |
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Inclusion Criteria:
Age >18 years
On dialysis > 6 months with a stable dialysis program
Consistent achievement of a spKt/V ≥ 1.2
HGB ≥ 10 gm% ± ESA support
Consistent failure to achieve a post weight ≤ dry weight + 0.5Kg
Able to give informed consent directly
Frequent hypotensive reactions (≥ 1 / treatment in 4 of last 8 treatments)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centers for Dialysis Care - East | Cleveland | Ohio | 44106 | United States |
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| Decrease dialysate temperature. | Other | Upon device notification event 2, decrease dialysate temperature by 0.5 degree centigrade. |
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| Decrease ultrafiltration rate by 25%. | Other | Upon device notification event 3, decrease ultrafiltration rate by 25% from baseline ultrafiltration rate. |
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| Decrease ultrafiltration rate by 50%. | Other | Upon device notification event 4, decrease ultrafiltration rate by 50% from baseline ultrafiltration rate. |
|
| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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