Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT05454735
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05454735
Study Brief:
Protocol Section:
NCT05454735