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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.
April 13, 2010
April 15, 2010
May 27, 2016
July 2007
May 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01103895 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.
Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass
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."
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Measurement of cardiac output before and after cardiopulmonary bypass in adult patients.
Cardiac Output
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
May 2012
May 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01103895
TSI-C-HCE101-4A-H
2R44HL082022-02 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: No
Transonic Systems Inc.
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Nikolai Krivitski, PhD, DSc Transonic Systems Inc.
Principal Investigator: Edward P Nast, MD Arnot Ogden Medical Center
Transonic Systems Inc.
May 2016