Pilot Study Using a Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Hemodialysis Ultrafiltration
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | August 2015 |
Use of Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Ultrafiltration in Hemodialysis Patients to Achieve Euvolemia While Minimizing Intra-dialytic Hypotension
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.
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.
Inclusion Criteria:
1. Age >18 years
2. On dialysis > 6 months with a stable dialysis program
3. Consistent achievement of a spKt/V ≥ 1.2
4. HGB ≥ 10 gm% ± ESA support
5. Consistent failure to achieve a post weight ≤ dry weight + 0.5Kg
6. Able to give informed consent directly
7. Frequent hypotensive reactions (≥ 1 / treatment in 4 of last 8 treatments)
- Symptoms of hypotension
- Intervention administered because of IDH (saline, "turn downs, early
termination, trendelenberg position)
- Drop in BP irrespective of symptoms. SBP < 90 mmHG intra or post HD if pre SBP
was > 110 mmHG; SBP < 85 mmHG or 15 mmHG drop from start if starting BP ≤ 110
mmHG.
- Or judged by the nursing staff to be difficult to achieve dry weight.
Exclusion Criteria:
1. Dialysis Catheter Access that may interfere with continuous data collection, per PI
determination. (Catheter access is a relative exclusion based on the history of
catheter performance.)
2. Cognitive Impairment precluding cooperation, and consent
3. Restless or unlikely to wear the monitor head-band
4. Too unstable in the judgment of their nephrologist to be included in a study of this
nature.
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