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NCT Number: NCT05454735

Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients

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.

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Key information

Conditions

Blood Glucose Variability Autonomic Nervous System Cardiac Surgical Procedures

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Post operative intensive care unit of the cardiac surgery department

Besançon, 25030, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Coronary artery bypass surgery

Procedure

coronary artery bypass surgery

aortic valve replacement surgery

Procedure

aortic valve replacement surgery

Primary outcomes

  1. 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

  1. Autonomic nervous system activity, measured by non-invasive continuous heart rate monitoring, calculated by measuring the R-R interval

    Time frame: From the day before surgery (at admission in the cardiac surgery department the day before surgery) to Day 3 after surgery

    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.

  2. Vasopressine blood level

    Time frame: The day before surgery, at admission in the postoperative intensive care unit, at day 1 and at day 2 after surgery

    Vasopressine blood level will be measured from blood samples to assess the relationship between blood glucose variability and endothelial dysfunction.

  3. Autonomic nervous system activity

    Time frame: The day before surgery.

    Compass 31 scale: the Compass 31 scale is a validated clinical scale that allows to identify the degree au autonomic nervous system dysfunction.

  4. Endocan blood level

    Time frame: The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery.

    Endocan blood level will be measured from blood samples to assess the relationship between blood glucose variability and endothelial dysfunction.

  5. 8-iso PGF2a urinary level

    Time frame: 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 will be measured from urinary samples to assess the relationship between blood glucose variability and oxidative stress.

  6. IL-6 blood level

    Time frame: 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 will be measured from blood samples to assess the relationship between blood glucose variability and systemic inflammation.

  7. IL-10 blood level

    Time frame: 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 will be measured from blood samples to assess the relationship between blood glucose variability and systemic inflammation.

  8. TNF-alpha blood level

    Time frame: 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 will be measured from blood samples to assess the relationship between blood glucose variability and systemic inflammation.

  9. Angiotensine blood level

    Time frame: 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 will be measured from blood samples to assess the relationship between blood glucose variability and endothelial dysfunction.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Perioperative Blood Glucose Variability and Autonomic Nervous System Activity in On-pump Cardiac Surgery Patients: Study Protocol of a Single-center Observational Study.

Acronym: CAESAR

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2022
Registry last updated
Apr 23, 2025

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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