Clinical trial NCT01389947: Microcirculation During Extracorporeal Circulation
Official title: Study of Non Major Microcirculation During Extracorporeal Circulation : Relation Between Endothelial Dysfunction and Digestive
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mesenteric Ischemia
Keywords: mesenteric ischemia
extracorporeal circulation
microcirculation
cardiac surgery
IFABP
citrullinemia
glycocalyx
vascular occlusion test
NIRS probe on thenar eminence
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who need surgical revascularization of coronary arteries. Patients can not not benefit of percutaneous coronary intervention and need a cardiac surgery of coronary artery bypass grafting

Brief summary: Digestive tract is supposed to be the motor of multiple organ failure. In ICU patients, mesenteric ischemia appears even when macrocirculatory parameters are controlled especially in our experience in patients coming in ICU after a cardiac surgery. The investigators suppose that microcirculatory failure develops and results in suffering of non major organs like muscle, skin and digestive tracts. In this study the investigators monitor digestive tract with plasmatic IFABP dosage and microcirculatory circulation with NIRS during a VOT and plasma glycocalyx measurements. The population is composed by patients having coronary artery bypass during cardiopulmonary bypass.

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.

Detailed description: Population study is patients who benefit from coronary artery bypass grafting under extracorporeal circulation support during intervention. Extracorporeal circulation result in SIRS. We aim to study digestive tract during this intervention.

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.

Eligibility criteria: Inclusion Criteria:

* coronary artery bypass grafting without any other surgery
* surgery made under extracorporeal circulation
* the same surgeon is operating each time

For the heart beating group, inclusion criteria are :

* coronary artery bypass grafting without any other surgery
* surgery performed under "heart beating" conditions.
* no matter about the surgeon that perform surgery

Exclusion Criteria:

* age under 18
* pregnancy
* refusing participation

Primary outcomes:
measure: Proving that digestive failure appears with extracorporeal circulation for cardiac surgery and is more frequent than the 1 to 3 % percent admitted in precedent studies using clinical endpoints.
timeFrame: 24 hours
Secondary outcomes:
measure: Study links between endothelial impairment and digestive suffering
timeFrame: 24 hours
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Jean Minjoz
state: Franche-Comté
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Cyril Manzon
role: PRINCIPAL_INVESTIGATOR
References: