Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study Using a Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Hemodialysis Ultrafiltration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02264522
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : August 30, 2016
Sponsor:
Collaborator:
Centers for Dialysis Care, Inc
Information provided by (Responsible Party):
Intelomed, Inc.

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Ohio
Centers for Dialysis Care - East
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Intelomed, Inc.
Centers for Dialysis Care, Inc

Layout table for additonal information
Responsible Party: Intelomed, Inc.
ClinicalTrials.gov Identifier: NCT02264522     History of Changes
Other Study ID Numbers: 04-14-39
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Vascular Diseases
Cardiovascular Diseases
Dialysis Solutions
Pharmaceutical Solutions