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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 is a NA study that has completed, run by Intelomed. The registered enrollment target is 10 participants.

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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.

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

Sponsor

Intelomed

5 total trials

What the Registry Record Tells You About NCT02264522

The ClinicalTrials.gov registry entry for NCT02264522 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intelomed, which has 5 total studies on file at ClinicalTrials.gov.

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

NCT02264522 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.