- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379638
Best Cardiac Output During Cardiopulmonary Bypass
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aalborg, Denmark, 9100
- Alborg Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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cardiac output
Adult patients undergoing cardiac surgery with normothermic cardiopulmonary bypass
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bodil Steen Rasmussen, MD, PhD, Aalborg University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- N-20080035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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