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Estimating and Predicting Hemodynamic Changes During Hemodialysis

Estimating and Predicting Hemodynamic Changes During Hemodialysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01700465
Enrollment
241
Registered
2012-10-04
Start date
2012-09-30
Completion date
2016-12-31
Last updated
2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis

Keywords

Hemodialysis, Hemodynamics

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

Interventions

None listed

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Acute intravascular volume loss during hemodialysisone hemodialysis session (approx 3-4 hours)development of algorithm to estimate acute intravascular volume loss during hemodialysis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026