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On-pump coronary artery bypass graft (CABG) and valve replacement surgeries are high-risk procedures. Among the risk factors for postoperative complications, perioperative hyperglycemia and blood glucose variability have been reported to be associated with increased morbidity and mortality. The treatment of hyperglycemia using intravenous insulin infusion improves the prognosis in cardiac surgery patients. However, the determinants of postoperative blood glucose variability and the mechanisms leading to its deleterious impact are unknown. Thus, to date, there is no therapeutic intervention that could effectively prevent and treat the deleterious impact of glycemic variability on postoperative outcome. The purpose of the study is to evaluate whether perioperative alteration of the autonomic nervous system and preoperative blood glucose variability could be related to perioperative glycemic variability.
The main objective is to describe the relationship between preoperative glycemic variability and glycemic variability during the first 48 postoperative hours.
The secondary objectives are :
to describe the relationship between preoperative glycemic variability and glycemic variability during the first 48 hours postoperative according to:
to describe the relationship between the parameters evaluating the preoperative activity of the autonomic nervous system and:
to describe the relationship between glycemic variability during the first 48 postoperative hours and:
to describe the morbidity and mortality within 30 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | patients with known insulin-requiring type 2 diabetes mellitus undergoing planned on-pump coronary artery bypass graft surgery |
| |
| Group 2 | patients with known non-insulin-requiring type 2 diabetes mellitus undergoing planned on-pump coronary artery bypass surgery |
| |
| Group 3 | non-diabetic patients undergoing planned aortic valve replacement surgery |
| |
| Group 4 | non-diabetic patients undergoing planned on-pump coronary artery bypass graft surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coronary artery bypass surgery | Procedure | coronary artery bypass surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability, measured by subcutaneous blood glucose continuous monitoring sensor, calculated by the coefficient of glycemic variability | Continuous blood glucose monitoring using a subcutaneous blood glucose continuous monitoring sensor (FreeStyle Libre Pro) | From 14 days before surgery (at least 48 hours before surgery) to 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Autonomic nervous system activity, measured by non-invasive continuous heart rate monitoring, calculated by measuring the R-R interval | Continuous non-invasive continuous heart rate monitoring using the MooKy HR memory device will allow the continuous measurement of the R-R interval and the R-R interval variability to quantify the activity of the autonomic nervous system. | From the day before surgery (at admission in the cardiac surgery department the day before surgery) to Day 3 after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Diabetic and non-diabetic adult patients undergoing planned on-pump cardiac surgery
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume BESCH, MD, PhD | Centre Hospitalier Universitaire de Besancon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post operative intensive care unit of the cardiac surgery department | Besançon | 25030 | France |
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| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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urinary and blood sample
| aortic valve replacement surgery | Procedure | aortic valve replacement surgery |
|
| Vasopressine blood level | Vasopressine blood level will be measured from blood samples to assess the relationship between blood glucose variability and endothelial dysfunction. | The day before surgery, at admission in the postoperative intensive care unit, at day 1 and at day 2 after surgery |
| Autonomic nervous system activity | Compass 31 scale: the Compass 31 scale is a validated clinical scale that allows to identify the degree au autonomic nervous system dysfunction. | The day before surgery. |
| Endocan blood level | Endocan blood level will be measured from blood samples to assess the relationship between blood glucose variability and endothelial dysfunction. | The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery. |
| 8-iso PGF2a urinary level | 8-iso PGF2a urinary level will be measured from urinary samples to assess the relationship between blood glucose variability and oxidative stress. | The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery. |
| IL-6 blood level | IL-6 blood level will be measured from blood samples to assess the relationship between blood glucose variability and systemic inflammation. | The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery. |
| IL-10 blood level | IL-10 blood level will be measured from blood samples to assess the relationship between blood glucose variability and systemic inflammation. | The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery. |
| TNF-alpha blood level | TNF-alpha blood level will be measured from blood samples to assess the relationship between blood glucose variability and systemic inflammation. | The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery. |
| Angiotensine blood level | Angiotensine blood level will be measured from blood samples to assess the relationship between blood glucose variability and endothelial dysfunction. | The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery. |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |