Clinical Trials Directory

Trials / Completed

CompletedNCT01700465

Estimating and Predicting Hemodynamic Changes During Hemodialysis

Status
Completed
Phase
Study type
Observational
Enrollment
241 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
2 Years – 89 Years
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2012-09-01
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2012-10-04
Last updated
2016-12-05

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01700465. Inclusion in this directory is not an endorsement.