Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients

NCT05454735 | Completed

• 1 other identifier: 2021/616
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Glucose Variability; Cardiac Surgical Procedures; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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

• Autonomic nervous system activity

  The day before surgery.

• 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.

Study Arms (4)

Group 1

patients with known insulin-requiring type 2 diabetes mellitus undergoing planned on-pump coronary artery bypass graft surgery

Procedure: coronary artery bypass surgery

Group 2

patients with known non-insulin-requiring type 2 diabetes mellitus undergoing planned on-pump coronary artery bypass surgery

Procedure: coronary artery bypass surgery

Group 3

non-diabetic patients undergoing planned aortic valve replacement surgery

Procedure: aortic valve replacement surgery

Group 4

non-diabetic patients undergoing planned on-pump coronary artery bypass graft surgery

Procedure: coronary artery bypass surgery

Interventions

coronary artery bypass surgery PROCEDURE

coronary artery bypass surgery

Group 1; Group 2; Group 4

aortic valve replacement surgery PROCEDURE

aortic valve replacement surgery

Group 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetic and non-diabetic adult patients undergoing planned on-pump cardiac surgery

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Post operative intensive care unit of the cardiac surgery department

Besançon, 25030, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urinary and blood sample

MeSH Terms

Interventions

Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Guillaume BESCH, MD, PhD

  Centre Hospitalier Universitaire de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: July 12, 2022
• Study Start: October 10, 2022
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-01

Locations

FR (1)