Glycemic Targets During CPB in Elderly Diabetes

N/ANot Yet RecruitingNCT07485101

Beijing Anzhen Hospital3,000 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

3,000

Conditions

Glycemic Management During CPB in Elderly Diabetic Cardiac Surgery

Interventions

Participants receive IV insulin infusion during cardiopulmonary bypass (CPB) to maintain blood glucose between 5-8 mmol/L. Monitoring is performed every 30 minutes. Hypoglycemia (\<70 mg/dL) is treated with glucose and insulin suspension. Severe hypoglycemia (\<54 mg/dL) triggers immediate reporting to the Safety Monitoring Committee. All interventions follow a standardized algorithm.

Liberal Glycemic Management ProtocolOTHER

Participants receive IV insulin infusion during cardiopulmonary bypass (CPB) to maintain blood glucose between 11-14 mmol/L. Monitoring is performed every 30 minutes. Safety protocols for hypoglycemia (rescue glucose for \<70 mg/dL and reporting for \<54 mg/dL) are identical to the active control group. All interventions follow a standardized algorithm.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Composite of major adverse cardio-cerebro-renal and vascular events (MACCE+)

A composite of major complications defined as: All-cause mortality: Death from any cause. CSA-AKI: KDIGO Stage 1-3. Perioperative MI: According to the 4th Universal Definition of MI (2018). For CABG-related MI (within 48h), defined as cTn \>10x 99th percentile URL with new pathological Q-waves/LBBB, new graft/native coronary occlusion, or new loss of viable myocardium/WMA. For non-CABG, cTn \>99th percentile URL with ischemic symptoms, new ST-T changes/LBBB, or pathological Q-waves. Stroke: New intracranial hemorrhage or infarction confirmed by CT, with or without neurological deficits (e.g., motor/sensory impairment, aphasia). Hepatic Dysfunction: Grade ≥3 according to CTCAE v6.0.