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Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.

This study has been terminated.
(Lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01103895
First Posted: April 15, 2010
Last Update Posted: May 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Transonic Systems Inc.
  Purpose
Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard."

Condition
Cardiac Output

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass

Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • Cardiac output after cardiopulmonary bypass [ Time Frame: Less than 10 minutes ]
    Cardiac output will be measured using an ultrasound dilution technique and compared with cardiac output measured using thermodilution after the completion of surgical procedures involving cardiopulmonary bypass.


Secondary Outcome Measures:
  • Cardiac output before cardiopulmonary bypass [ Time Frame: Less than 10 minutes ]
    Cardiac output will be measured using an ultrasound dilution technique and compared to cardiac output measured using thermodilution. This will serve as a baseline measurement of the patient's cardiac output.


Enrollment: 14
Study Start Date: July 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Measurement of cardiac output before and after cardiopulmonary bypass in adult patients.
Criteria

Inclusion Criteria:

  • Patients aged > 21 years
  • Patients undergoing surgery involving cardiopulmonary bypass
  • Patients instrumented with a thermodilution catheter

Exclusion Criteria:

  • Patients aged < 21 years
  • Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103895


Locations
United States, New York
Arnot Ogden Medical Center
Elmira, New York, United States, 14905
Sponsors and Collaborators
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Nikolai Krivitski, PhD, DSc Transonic Systems Inc.
Principal Investigator: Edward P Nast, MD Arnot Ogden Medical Center
  More Information

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT01103895     History of Changes
Other Study ID Numbers: TSI-C-HCE101-4A-H
2R44HL082022-02 ( U.S. NIH Grant/Contract )
First Submitted: April 13, 2010
First Posted: April 15, 2010
Last Update Posted: May 27, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Transonic Systems Inc.:
cardiac output
cardiopulmonary bypass
ultrasound dilution


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