Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
66 participants
OBSERVATIONAL
2011-03-31
2012-02-29
Brief Summary
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The first aim of this study is to show that digestive tract is suffering with the use of extracorporeal circulation and will be assessed with Plasmatic Intestinal Fatty Acid Binding Protein when IFABP will more than 300 pg/ml ; and with citrullinemia when citrullinemia will be less than 20 micromol/L.
The second aim is to investigate link between endothelial dysfunction and digestive tract. Endothelial dysfunction is assessed with tissular oxygen saturation before, during and after a vascular occlusion test of 3 minutes (measurement of basal value, desaturation curve, resaturation curve and hyperemic response by measurement of area under curve). Endothelial glycocalyx and NO pathway will be investigate (see under)
Our objective is to enroll 100 patients. The same study will be done in a group of patients who benefit from coronary artery bypass without extracorporeal circulation to see the effects of extracorporeal circulation support.
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Detailed Description
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There are 5 times of measurements : under stable hemodynamic conditions and after beginning of anesthesia, just at the end of extracorporeal circulation, about 15 minutes following aortic unclamping and at the end of the Protamine perfusion, about 90 minutes after the end of extracorporeal circulation and the last time measurement 24 hours later.
At each time measurement are done : blood samples to measure Intestinal Fatty Acid Binding Protein, Citrullinemia that are markers for digestive suffering ; blood samples for measurement of Syndecan 1 CD 138 and Heparan Sulfate, two markers of shedding of the endothelial glycocalyx; blood samples for measurement of NOx and GMPc to assess the NO pathway ; measurement of tissular oxygen saturation with a NIRS probe, before, during and after a vascular occlusion test of 3 minutes. Blood samples for hemoglobin, platelets, coagulation evaluation, urea, creatininemia, liver enzymes and pancreatic enzymes will be done at each time.
The vascular occlusion test is done the day before the surgery when patient is awake without any exercise. This is a reference measurement.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Extracorporeal circulation
Patients who have coronary artery bypass graft performed under extracorporeal circulation
No interventions assigned to this group
Heart beating group
Patients who have a coronary artery bypass graft without extracorporeal circulation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* surgery made under extracorporeal circulation
* the same surgeon is operating each time
* coronary artery bypass grafting without any other surgery
* surgery performed under "heart beating" conditions.
* no matter about the surgeon that perform surgery
Exclusion Criteria
* pregnancy
* refusing participation
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Loic Barrot
PH
Principal Investigators
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Cyril Manzon
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Besancon
Locations
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CHU Jean Minjoz
Besançon, Franche-Comté, France
Countries
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Other Identifiers
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P/2010/105
Identifier Type: -
Identifier Source: org_study_id
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