Best Cardiac Output During Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by:
Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT01379638
First received: June 22, 2011
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

The purpose of this study is to determine whether the patients cardiac output measured before cardiopulmonary bypass (CPB), is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.


Condition
Bypass Complications

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Best Cardiac Output During Cardiopulmonary Bypass

Further study details as provided by Aalborg Universityhospital:

Enrollment: 20
Study Start Date: December 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
cardiac output
Adult patients undergoing cardiac surgery with normothermic cardiopulmonary bypass

Detailed Description:

For more than 50 years, CPB has been used to mechanically support the functions of the heart and lungs. In early studies, systemic oxygen uptake, calculated using Ficks global principle, was used to assess the efficiency of CPB. Using this measure of efficiency, a pump flow rate in liters per minute, based on the product of the body surface area (BSA) and a constant of 2.4 was found adequate to perfuse the body during normothermia. Ficks global principle is still used together with other methods to secure adequated perfusion under CPB.

The purpose of this study is to determine whether the patients cardiac output measured before CPB, is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

The hypothesis is that the patients cardiac output is a better marker for the optimal cardiac output than the estimated cardiac output.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients to be admitted to Aalborg Hospital, department of cardiac surgery for scheduled cardiac surgery

Criteria

Inclusion Criteria:

  • patients admitted for scheduled cardiac surgery during cardiopulmonary bypass
  • Aged 18-90 years
  • LVEF > 50 %
  • written consent from the patients

Exclusion Criteria:

  • Former cerebral emboli
  • Former head trauma
  • known stenosis of the arteria carotis
  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: NCT01379638

Locations
Denmark
Alborg Hospital
Aalborg, Denmark, 9100
Sponsors and Collaborators
Aalborg Universityhospital
Investigators
Study Director: Bodil Steen Rasmussen, MD, PhD Aalborg Universityhospital
  More Information

No publications provided

Responsible Party: Sisse Anette Thomassen, Department of cardiothoracic surgery and anesthesiology
ClinicalTrials.gov Identifier: NCT01379638     History of Changes
Other Study ID Numbers: N-20080035
Study First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Aalborg Universityhospital:
cardiopulmonary bypass
cardiac output
flow rate
lactate

ClinicalTrials.gov processed this record on August 19, 2014