Glycemic Targets During CPB in Elderly Diabetes

Effects of Two gLycemic targEts During Cardiopulmonary bypAss on Clinical Outcomes in Diabetic Elderly Patients Undergoing caRdiac Surgery (LEADER): A Randomized Controlled Trial

The goal of this clinical trial is to compare the effects of tight versus liberal glycemic management strategies on patient outcomes during cardiopulmonary bypass in elderly diabetic patients undergoing cardiac surgery. The main questions it aims to answer are:

• Which method of glycemic management could reduce the occurrence of postoperative major outcomes and other complications in patients?
• During cardiopulmonary bypass, are the range of glycemic
• fluctuations, the duration of hyperglycemia, and the incidence of hypoglycemia associated with the risk of postoperative complications?

Participants will:

• Blood sugar control and invasive glycemic monitoring during intraoperative cardiopulmonary bypass
• Record whether major endpoint events and secondary endpoint events occurred and the number of times
• Record intraoperative and postoperative physiological and biochemical indicators

Inclusion Criteria:

1. Age: age ≥ 60 years old.
2. Diagnosis: Preoperative diagnosis of Type 2 Diabetes Mellitus (T2DM), with a history of regular glucose-lowering therapy for at least 3 months prior to surgery.
3. Procedure: Undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB).
4. Complexity: Undergoing combined cardiac procedures (e.g., any combination of two or more of the following: CABG, valvular surgery, congenital heart repair, cardiomyopathy correction, or great vessel surgery).
5. Informed Consent: Willing and able to provide written informed consent.

Exclusion Criteria:

1. Surgical Factors: Emergency surgery, redo sternotomy, heart transplantation, or left ventricular assist device (LVAD) implantation.
2. Organ Dysfunction: Severe hepatic insufficiency (Child-Pugh Class C) or pre-existing dependence on renal replacement therapy (RRT).
3. Neurological Status: History of severe disabling stroke (mRS > 3) or dementia that prevents meaningful neurological assessment.
4. Acute Metabolic Complications: Occurrence of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) within 1 month prior to surgery, or a history of recurrent severe hypoglycemia within the past year.
5. Glycemic Baseline: Preoperative HbA1c > 10%.
6. Pregnancy/Lactation: Women who are currently pregnant or breastfeeding.
7. Life Expectancy: Terminal illness with an expected survival of less than 3 months.
8. Communication Barriers: Inability to effectively communicate or provide informed consent due to mental, legal, or other disabilities.
9. Co-enrollment: Concurrent participation in another perioperative interventional clinical trial.