NCT07485101

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Glycemic Management During CPB in Elderly Diabetic Cardiac Surgery

Interventions

Type	Name	Description
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。

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-30
• Completion: 2028-06-30
• First posted: 2026-03-20
• Last updated: 2026-03-20