Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.

This study has been terminated.
(Lack of enrollment)
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT01103895
First received: April 13, 2010
Last updated: May 25, 2016
Last verified: May 2016
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 13, 2010
Last Updated: May 25, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on July 24, 2016