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Measurement of Cardiac Output and Intravascular Volume Status in Children Using COstatus (SH)

Sponsor
Transonic Systems Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01613859
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
9
Enrollment
1
Location
28
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is an integral part of hemodynamic monitoring of critically ill patients whether it is done directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies to support the cardiovascular system in critically ill children with multi organ dysfunction. Because of the side effects involved in measuring cardiac output directly, intensive monitoring of patients is currently limited to an integrated assessment of tissue perfusion, oxygen delivery and cellular health both at regional and global levels. Currently available methods of measuring CO have their limitations and complications, and are not used routinely for bedside monitoring. Therefore, the investigators propose to use a newly developed method, termed COstatus for the monitoring of CO in patients admitted to PICU.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9 participants
    Time Perspective:
    Prospective
    Official Title:
    Measurement of Cardiac Output and Intravascular Volume Status in Critically Ill Children Using an Ultrasound Dilution Method (COstatus)
    Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    May 1, 2014
    Actual Study Completion Date :
    May 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Comparing CO and other clinical markers in Pediatric ICU [During patients stay in ICU with insitu catheter, expected average 3-4 days]

      The objective of this study is to see if the CO measurements obtained with COstatus show a linear correlation with all other indirect and invasive methods currently used to measure CO (within acceptable range) and with the CO measured by thermodilution in the cardiac catheterization lab.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients under 21 years

    2. Presence of compensated or decompensated shock irrespective of etiology

    3. Presence of an existing peripheral arterial and central venous catheters

    Exclusion Criteria:
    1. Patients allergic to heparin

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shands Children's Hospital, University of Florida Gainesville Florida United States 32608

    Sponsors and Collaborators

    • Transonic Systems Inc.
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Jai Udassi, MD, Shands Children's Hospital, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Transonic Systems Inc.
    ClinicalTrials.gov Identifier:
    NCT01613859
    Other Study ID Numbers:
    • TSI-G-COstatus-12A-H
    • R44HL061994
    First Posted:
    Jun 7, 2012
    Last Update Posted:
    May 27, 2016
    Last Verified:
    May 1, 2016

    Study Results

    No Results Posted as of May 27, 2016