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NCT02264522 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Intelomed.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT02264522: Completed NA study, sponsored by Intelomed.

NCT02264522 is a NA study that has completed, run by Intelomed. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02264522, a NA study, has completed, sponsored by Intelomed.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study 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.

Primary Outcome

Percent difference between prescribed dry weight and actual weight at end of dialysis session.

Interventions

  • OTHER Place dialysis chair into position 3.
  • OTHER Decrease dialysate temperature.
  • OTHER Decrease ultrafiltration rate by 25%.
  • OTHER Decrease ultrafiltration rate by 50%.

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2014-09
Est. Completion 2015-08
Phase NA
Intelomed

5 total trials

What the finished NCT02264522 record still lists

NCT02264522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 4 interventions - of which Place dialysis chair into position 3. is the first listed.

NCT02264522 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02264522 about?

NCT02264522 is a clinical study titled "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...

What is the current status of trial NCT02264522?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2014-09. Estimated completion is 2015-08.

What interventions are being tested in trial NCT02264522?

The interventions under investigation include: Place dialysis chair into position 3. (OTHER), Decrease dialysate temperature. (OTHER), Decrease ultrafiltration rate by 25%. (OTHER), Decrease ultrafiltration rate by 50%. (OTHER).

Who is sponsoring clinical trial NCT02264522?

This trial is sponsored by Intelomed, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02264522's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02264522, the US trial registry maintained by the National Library of Medicine. NCT02264522 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.