Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients (NCT05454735) | Clinical Trial Compass
CompletedNot Applicable
Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients
France120 participantsStarted 2022-10-10
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Trial details
NCT IDNCT05454735
SponsorCentre Hospitalier Universitaire de Besancon