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NCT Number: NCT02264522

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

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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Key information

Conditions

Intradialytic Hypotension Edema Hypervolemia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centers for Dialysis Care - East

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

  • 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.)
  • Cognitive Impairment precluding cooperation, and consent
  • Restless or unlikely to wear the monitor head-band
  • Too unstable in the judgment of their nephrologist to be included in a study of this nature.

Treatment and study plan

Place dialysis chair into position 3.

Other

Upon device notification event 1, place patient in dialysis chair position 3.

Decrease dialysate temperature.

Other

Upon device notification event 2, decrease dialysate temperature by 0.5 degree centigrade.

Decrease ultrafiltration rate by 25%.

Other

Upon device notification event 3, decrease ultrafiltration rate by 25% from baseline ultrafiltration rate.

Decrease ultrafiltration rate by 50%.

Other

Upon device notification event 4, decrease ultrafiltration rate by 50% from baseline ultrafiltration rate.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Intelomed, Inc.

Industry

Collaborators

  • Centers for Dialysis Care, Inc

Registry information

Official study title

Use of Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Ultrafiltration in Hemodialysis Patients to Achieve Euvolemia While Minimizing Intra-dialytic Hypotension

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2014
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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