Skip to main content
OpenTrials
Completed

NCT Number: NCT01700465

Estimating and Predicting Hemodynamic Changes During Hemodialysis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

2 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

Loading trial locations.

About this study

  • 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.
  • 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.
  • 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
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Acute intravascular volume loss during hemodialysis

    Time frame: one hemodialysis session (approx 3-4 hours)

    development of algorithm to estimate acute intravascular volume loss during hemodialysis

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 4, 2012
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.