Blood Glucose VariabilityCAESARNCT05454735
Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients
An observational study of Blood Glucose Variability and Cardiac Surgical Procedures, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Glucose Variability, Cardiac Surgical Procedures, Autonomic Nervous System
- What is being tested?
- coronary artery bypass surgery and aortic valve replacement surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic and non-diabetic adult patients undergoing planned on-pump cardiac surgery
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Post operative intensive care unit of the cardiac surgery department
Besançon, 25030
About this study
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.
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.
Read the 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:
- 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.
- Being tested
- coronary artery bypass surgery, aortic valve replacement surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery bypass surgeryProcedure or surgery
coronary artery bypass surgery
aortic valve replacement surgeryProcedure or surgery
aortic valve replacement surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | patients with known insulin-requiring type 2 diabetes mellitus undergoing planned on-pump coronary artery bypass graft surgery Receives: 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 Receives: Procedure: coronary artery bypass surgery | |
| Group 3 | non-diabetic patients undergoing planned aortic valve replacement surgery Receives: Procedure: aortic valve replacement surgery | |
| Group 4 | non-diabetic patients undergoing planned on-pump coronary artery bypass graft surgery Receives: Procedure: coronary artery bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: From the day before surgery (at admission in the cardiac surgery department the day before surgery) to Day 3 after surgery
Vasopressine blood level
Vasopressine blood level will be measured from blood samples to assess the relationship between blood glucose variability and endothelial dysfunction.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The day before surgery, and at admission in the postoperative intensive care unit, and at day 1 and at day 2 after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start10 Oct 2022
- Primary completion31 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Glucose VariabilityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume BESCH, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454735
- Sponsor's protocol ID
- 2021/616
- Acronym
- CAESAR
- Status last verified
- Jan 2025
- First submitted
- 10 Jun 2022
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chazal E, Trajkovski J, Boitel A, Mille C, Legrand-Narboux C, Bronnert R, Grelet T, Guilhot M, Vettoretti L, Pili-Floury S, Besch G, Borot S. Preoperative and postoperative glycaemic variability in patients undergoing planned on-pump cardiac surgery: an observational cohort study. Br J Anaesth. 2026 Sep;137(3):690-694. doi: 10.1016/j.bja.2026.05.027. Epub 2026 Jul 22.
PubMed 42486704
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05454735
- Acronym / sponsor ID
- CAESAR / 2021/616
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: coronary artery bypass surgerypatients with known insulin-requiring type 2 diabetes mellitus undergoing planned on-pump coronary artery bypass graft surgery |
| Group 2 | – | Procedure: coronary artery bypass surgerypatients with known non-insulin-requiring type 2 diabetes mellitus undergoing planned on-pump coronary artery bypass surgery |
| Group 3 | – | Procedure: aortic valve replacement surgerynon-diabetic patients undergoing planned aortic valve replacement surgery |
| Group 4 | – | Procedure: coronary artery bypass surgerynon-diabetic patients undergoing planned on-pump coronary artery bypass graft surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic and non-diabetic adult patients undergoing planned on-pump cardiac surgery
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary artery bypass surgerycoronary artery bypass surgery | Procedure or surgery | Group 1, Group 2, Group 4 |
| aortic valve replacement surgeryaortic valve replacement surgery | Procedure or surgery | Group 3 |
Primary outcome
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)
9 secondary outcomes
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
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
Autonomic nervous system activity
Time frame: The day before surgery.
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.
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.
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-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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 42486704Chazal E, Trajkovski J, Boitel A, Mille C, Legrand-Narboux C, Bronnert R, Grelet T, Guilhot M, Vettoretti L, Pili-Floury S, Besch G, Borot S. Preoperative and postoperative glycaemic variability in patients undergoing planned on-pump cardiac surgery: an observational cohort study. Br J Anaesth. 2026 Sep;137(3):690-694. doi: 10.1016/j.bja.2026.05.027. Epub 2026 Jul 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume BESCH, MD, PhD principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Glucose Variability and Cardiac Surgical Procedures, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.