Glycemic Targets During CPB in Elderly Diabetes

Official title

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

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

Interventions

• Other Tight Glycemic Management Protocol
  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.
• Other Liberal Glycemic Management Protocol
  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.
• Drug Short-acting Insulin
  通过微量泵给予静脉胰岛素输注，以维持血糖在指定的目标范围内（11-14 mmol/L 或 5-8 mmol/L）。包括标准低血糖安全方案：当血糖 \<70 mg/dL 时给予救援葡萄糖，当血糖 \<54 mg/dL 时强制报告不良事件。

Primary outcome measures

• Composite of major adverse cardio-cerebro-renal and vascular events (MACCE+) [Time frame: From the day of surgery up to 30 days postoperatively]

Secondary outcome measures (12)

• Postoperative 30-day All-cause Mortality [Time frame: From the day of surgery up to 30 days postoperatively]
• Perioperative Renal Dysfunction (CSA-AKI) [Time frame: From the day of surgery up to 30 days postoperatively]
• Perioperative Myocardial Injury and Infarction (PMI) [Time frame: From the day of surgery up to 30 days postoperatively]
• Postoperative Stroke [Time frame: From the day of surgery up to 30 days postoperatively]
• Perioperative Hepatic Dysfunction [Time frame: From the day of surgery up to 30 days postoperatively]
• New-onset Symptomatic Respiratory Failure [Time frame: From the day of surgery up to 30 days postoperatively]
• Deep Sternal Wound Infection or Mediastinitis [Time frame: From the day of surgery up to 30 days postoperatively]
• New-onset Mechanical Circulatory Support [Time frame: From the day of surgery up to 30 days postoperatively]
• New-onset Symptomatic Atrial Fibrillation [Time frame: From the day of surgery up to 30 days postoperatively]
• New-onset In-hospital Infection [Time frame: From the day of surgery up to 30 days postoperatively]
• Duration of Postoperative Mechanical Ventilation [Time frame: From the day of surgery up to 30 days postoperatively (or until ICU discharge)]
• Length of Stay in the Intensive Care Unit (ICU) [Time frame: From the day of surgery up to 30 days postoperatively]

Eligibility criteria

Inclusion criteria

• Age: age ≥ 60 years old.
• 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.
• Procedure: Undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB).
• 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).
• Informed Consent: Willing and able to provide written informed consent.

Exclusion criteria

• Surgical Factors: Emergency surgery, redo sternotomy, heart transplantation, or left ventricular assist device (LVAD) implantation.
• Organ Dysfunction: Severe hepatic insufficiency (Child-Pugh Class C) or pre-existing dependence on renal replacement therapy (RRT).
• Neurological Status: History of severe disabling stroke (mRS > 3) or dementia that prevents meaningful neurological assessment.
• 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.
• Glycemic Baseline: Preoperative HbA1c > 10%.
• Pregnancy/Lactation: Women who are currently pregnant or breastfeeding.
• Life Expectancy: Terminal illness with an expected survival of less than 3 months.
• Communication Barriers: Inability to effectively communicate or provide informed consent due to mental, legal, or other disabilities.
• Co-enrollment: Concurrent participation in another perioperative interventional clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07485101 · TBD123456789

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗