Estimating and Predicting Hemodynamic Changes During Hemodialysis

Completed

• Conditions: Hemodialysis

• Registration Number: NCT01700465
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Machine learning techniques and algorithms originally developed for use in the field of robotics can be applied to continuous, noninvasive physiological waveform data to discover hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) estimate acute blood loss volume, 2) monitor and estimate fluid resuscitation needs, 3) predict cardiovascular collapse well ahead of any clinically significant changes in standard vital signs, and 4) estimate intracranial pressure. We hypothesize that these same methods can be used to monitor volume loss during hemodialysis, as well as predict intradialytic hypotension, well before it occurs.

Detailed Description

1. Collect physiological waveform data from patients undergoing hemodialysis at the University of Colorado Hospital, Children's Hospital Colorado, and Fresenius Medical Centers using non-invasive monitoring techniques.

2. Combine the physiological data from patient monitors with clinical and demographic data, including age, gender, race, problem list, reason for dialysis, estimated dry weight, volume removed, arterial and venous pressures, etc. for use in developing mathematical models of hemodialysis.

3. Develop robust, real-time, computational models for:

* estimating acute intravascular volume loss during hemodialysis

* predicting an optimal, individual specific, intravascular volume to be removed during a hemodialysis session

* predicting intradialytic hypotension

4. Determine:

* which non-invasive signals are relevant to each model type

* which features extracted from these signals are relevant

* which algorithms are capable of using the extracted features for each decision type

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-04
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• Age: 2 - 89 years
• Undergoing hemodialysis at the Fresenius Medical Centers, University of Colorado Hospital or Children's Hospital Colorado

Read More

Exclusion Criteria

• Pregnant
• Incarcerated
• Decisionally challenged
• Positive for hepatitis B surface antigen
• Limited access to or compromised monitoring sites for non-invasive finger and ear or forehead sensors

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute intravascular volume loss during hemodialysis	one hemodialysis session (approx 3-4 hours)	development of algorithm to estimate acute intravascular volume loss during hemodialysis

Trial Locations

Locations (5)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Fresenius Medical Center East Denver; 🇺🇸 Aurora, Colorado, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Fresenius Medical Center Central; 🇺🇸 Denver, Colorado, United States

Fresenius Medical Center Rocky Mountain; 🇺🇸 Denver, Colorado, United States