Perioperative Blood Glucose Variability and Autonomic Nervous System Activity in On-pump Cardiac Surgery Patients: Study Protocol of a Single-center Observational Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Glycemic variability, measured by subcutaneous blood glucose continuous monitoring sensor, calculated by the coefficient of glycemic variability
Study Overview
Brief Summary
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.
Detailed Description
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:
- diabetic and non-diabetic status
- the type of surgical intervention
- to describe the relationship between the parameters evaluating the preoperative activity of the autonomic nervous system and:
- preoperative glycemic variability
- glycemic variability during the first 48 postoperative hours
- to describe the relationship between glycemic variability during the first 48 postoperative hours and:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Planned cardiac surgery
- •Age ≥ 18 years old and < 80 years old
- •Group 1: patients with known insulin-requiring type 2 diabetes mellitus undergoing planned on-pump coronary artery bypass 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 surgery
Exclusion Criteria
- •Emergent surgery (less than 48 hours between anesthestetic consultation and surgery)
- •Combined surgery (coronary artery bypass graft associated with valve surgery, multiple valve replacement, surgery of the ascending aorta)
- •Extreme weight: body mass index (BMI) > 35 kg.m-2 or < 18 kg.m-
- •Off-pump coronary artery bypass graft surgery
- •Type 1 diabetes mellitus
- •Patient unable to consent
- •Pregnant and/or breastfeeding woman
- •Permanent preoperative chronic heart rhythm disorder
- •Pacemaker
- •Unstable patient condition in preoperative period
- •Expected life expectancy less than 48 hours.
- •Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator.
- •Duration of continuous preoperative glycemic recording of less than 48 hours.
Outcomes
Primary Outcomes
Glycemic variability, measured by subcutaneous blood glucose continuous monitoring sensor, calculated by the coefficient of glycemic variability
Time Frame: From 14 days before surgery (at least 48 hours before surgery) to 7 days after surgery
Continuous blood glucose monitoring using a subcutaneous blood glucose continuous monitoring sensor (FreeStyle Libre Pro)
Secondary Outcomes
- Endocan blood level(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(The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery.)
- Autonomic nervous system activity(The day before surgery.)
- Autonomic nervous system activity, measured by non-invasive continuous heart rate monitoring, calculated by measuring the R-R interval(From the day before surgery (at admission in the cardiac surgery department the day before surgery) to Day 3 after surgery)
- Vasopressine blood level(The day before surgery, at admission in the postoperative intensive care unit, at day 1 and at day 2 after surgery)
- IL-10 blood level(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(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(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(The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery.)