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Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT02264522

Public ClinicalTrials.gov record NCT02264522. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 7:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02264522
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Intelomed, Inc.
Industry
Enrollment
10 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2014
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015
Last update posted
Aug 29, 2016

2014 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Centers for Dialysis Care - East Cleveland Ohio 44106

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02264522, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 29, 2016 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02264522 live on ClinicalTrials.gov.

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