Clinical trial NCT05454735: Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients
Official title: Perioperative Blood Glucose Variability and Autonomic Nervous System Activity in On-pump Cardiac Surgery Patients: Study Protocol of a Single-center Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Glucose Variability
Cardiac Surgical Procedures
Autonomic Nervous System
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic and non-diabetic adult patients undergoing planned on-pump cardiac surgery

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 :

1. 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
2. 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
3. to describe the relationship between glycemic variability during the first 48 postoperative hours and:

   * parameters evaluating the activity of the autonomic nervous system during the first 48 postoperative hours
   * diabetes phenotype
   * markers of inflammation
   * markers of endothelial dysfunction
4. to describe the morbidity and mortality within 30 days after surgery.

Eligibility criteria: 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-2.
* 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.

Primary outcomes:
measure: Glycemic variability, measured by subcutaneous blood glucose continuous monitoring sensor, calculated by the coefficient of glycemic variability
timeFrame: From 14 days before surgery (at least 48 hours before surgery) to 7 days after surgery
Secondary outcomes:
measure: Autonomic nervous system activity, measured by non-invasive continuous heart rate monitoring, calculated by measuring the R-R interval
timeFrame: From the day before surgery (at admission in the cardiac surgery department the day before surgery) to Day 3 after surgery
measure: Vasopressine blood level
timeFrame: The day before surgery, at admission in the postoperative intensive care unit, at day 1 and at day 2 after surgery
measure: Autonomic nervous system activity
timeFrame: The day before surgery.
measure: Endocan blood level
timeFrame: The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery.
measure: 8-iso PGF2a urinary level
timeFrame: The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery.
measure: IL-6 blood level
timeFrame: The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery.
measure: IL-10 blood level
timeFrame: The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery.
measure: TNF-alpha blood level
timeFrame: The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery.
measure: Angiotensine blood level
timeFrame: The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery.
Other outcomes:
Locations:
city: Besançon
country: France
facility: Post operative intensive care unit of the cardiac surgery department
Study officials:
affiliation: Centre Hospitalier Universitaire de Besançon
name: Guillaume BESCH, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: