Microcirculation During Extracorporeal Circulation

NCT01389947 | Completed DMC

• 1 other identifier: P/2010/105
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesenteric Ischemia

Keywords

mesenteric ischemia; extracorporeal circulation; microcirculation; cardiac surgery; IFABP; citrullinemia; glycocalyx; vascular occlusion test; NIRS probe on thenar eminence

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  24 hours

Secondary Outcomes (1)

• Study links between endothelial impairment and digestive suffering

  24 hours

Study Arms (2)

Extracorporeal circulation

Patients who have coronary artery bypass graft performed under extracorporeal circulation

Heart beating group

Patients who have a coronary artery bypass graft without extracorporeal circulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• coronary artery bypass grafting without any other surgery
• 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

You may not qualify if:

• age under 18
• pregnancy
• refusing participation

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Jean Minjoz

Besançon, Franche-Comté, 25000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma measurments Tissular oxygen saturation using NIRS probe

MeSH Terms

Conditions

Mesenteric Ischemia; Citrullinemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Cyril Manzon

  Centre Hospitalier Universitaire de Besancon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PH

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: July 8, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 9, 2012

Record last verified: 2012-02

Locations

FR (1)