Pilot Study Using a Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Hemodialysis Ultrafiltration
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|ClinicalTrials.gov Identifier: NCT02264522|
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : August 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Intradialytic Hypotension Hypervolemia||Other: Place dialysis chair into position 3. Other: Decrease dialysate temperature. Other: Decrease ultrafiltration rate by 25%. Other: Decrease ultrafiltration rate by 50%.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Ultrafiltration in Hemodialysis Patients to Achieve Euvolemia While Minimizing Intra-dialytic Hypotension|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: Single Arm
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%".
Other: Place dialysis chair into position 3.
Upon device notification event 1, place patient in dialysis chair position 3.
Other: Decrease dialysate temperature.
Upon device notification event 2, decrease dialysate temperature by 0.5 degree centigrade.
Other: Decrease ultrafiltration rate by 25%.
Upon device notification event 3, decrease ultrafiltration rate by 25% from baseline ultrafiltration rate.
Other: Decrease ultrafiltration rate by 50%.
Upon device notification event 4, decrease ultrafiltration rate by 50% from baseline ultrafiltration rate.
- Difference between prescribed dry weight and actual measured weight at end of dialysis session. [ Time Frame: 8 weeks ]Percent difference between prescribed dry weight and actual weight at end of dialysis session.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264522
|United States, Ohio|
|Centers for Dialysis Care - East|
|Cleveland, Ohio, United States, 44106|