Microcirculation During Extracorporeal Circulation

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.

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Key information

Conditions

Mesenteric Ischemia Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Citrullinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Peritoneal Diseases Urea Cycle Disorders, Inborn Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Jean Minjoz

Besançon, Franche-Comté, 25000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Time frame: 24 hours

Digestive suffering will be assessed by clinical measurment (pain, vomiting), classical biologic measurment and new specific measurment (intestinal fatty acid binding protein : IFABP and citrullinemia. Plasmatic IFABP of more than 300 pg/ml and citrullinemia of more than 20 micromol/L are used as cut-off to define intestinal failure.

Microcirculatory will be assessed via a Near InfraRed Spectroscopy (NIRS) probe ajusted on the thenar eminence for the tissular oxygen saturation measurment before, during and after a vascular occlusion test of 3 minutes.

Secondary outcomes

Study links between endothelial impairment and digestive suffering

Time frame: 24 hours
Digestive suffering was define before.

Endothelial impairment is define using :
- Tissular Oxygen Saturation during vascular occlusion test. The reasturation curve represents endothelial vasodilatory capacities
- Elevation of Syndecan and Heparan shows the shedding of endothelial glycocalyx We will study the links and the correlation between syndecan and heparan elevation with diminution of resaturation curve and digestive suffering NOx and GMPc will help us for the interpretation of NIRS curves.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Study of Non Major Microcirculation During Extracorporeal Circulation : Relation Between Endothelial Dysfunction and Digestive

Acronym: CITRON4

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2012
First posted: Jul 8, 2011
Registry last updated: Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed