Best Cardiac Output During Cardiopulmonary Bypass
| Tracking Information | |||||
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| First Received Date ICMJE | June 22, 2011 | ||||
| Last Updated Date | June 22, 2011 | ||||
| Start Date ICMJE | December 2008 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Best Cardiac Output During Cardiopulmonary Bypass | ||||
| Official Title ICMJE | Best Cardiac Output During Cardiopulmonary Bypass | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients to be admitted to Aalborg Hospital, department of cardiac surgery for scheduled cardiac surgery |
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| Condition ICMJE | Bypass Complications | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | cardiac output
Adult patients undergoing cardiac surgery with normothermic cardiopulmonary bypass |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | January 2010 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01379638 | ||||
| Other Study ID Numbers ICMJE | N-20080035 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sisse Anette Thomassen, Department of cardiothoracic surgery and anesthesiology | ||||
| Study Sponsor ICMJE | Aalborg Universityhospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Aalborg Universityhospital | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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