NCT07485101尚未招募不适用
Effects of Two gLycemic targEts During Cardiopulmonary bypAss on Clinical Outcomes in Diabetic Elderly Patients Undergoing caRdiac Surgery (LEADER): A Randomized Controlled Trial
Beijing Anzhen Hospital0 个研究点目标入组 3,000 人开始时间: 2026年4月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 主要终点
- Composite of major adverse cardio-cerebro-renal and vascular events (MACCE+)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Composite of major adverse cardio-cerebro-renal and vascular events (MACCE+)
时间窗: From the day of surgery up to 30 days postoperatively
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.
次要结局
- Postoperative 30-day All-cause Mortality(From the day of surgery up to 30 days postoperatively)
- Perioperative Renal Dysfunction (CSA-AKI)(From the day of surgery up to 30 days postoperatively)
- Perioperative Myocardial Injury and Infarction (PMI)(From the day of surgery up to 30 days postoperatively)
- Postoperative Stroke(From the day of surgery up to 30 days postoperatively)
- Perioperative Hepatic Dysfunction(From the day of surgery up to 30 days postoperatively)
- New-onset Symptomatic Respiratory Failure(From the day of surgery up to 30 days postoperatively)
- Deep Sternal Wound Infection or Mediastinitis(From the day of surgery up to 30 days postoperatively)
- New-onset Mechanical Circulatory Support(From the day of surgery up to 30 days postoperatively)
- Total Hospitalization Cost(From the day of surgery up to 30 days postoperatively)
- New-onset Symptomatic Atrial Fibrillation(From the day of surgery up to 30 days postoperatively)
- New-onset In-hospital Infection(From the day of surgery up to 30 days postoperatively)
- Duration of Postoperative Mechanical Ventilation(From the day of surgery up to 30 days postoperatively (or until ICU discharge))
- Length of Stay in the Intensive Care Unit (ICU)(From the day of surgery up to 30 days postoperatively)
- Postoperative Hospital Length of Stay(From the day of surgery up to 30 days postoperatively)
- Intraoperative Glycemic Variability during CPB(From initiation to termination of cardiopulmonary bypass)
- Time-Weighted Average (TWA) Glucose during CPB(From initiation to termination of cardiopulmonary bypass)
- Duration of Intraoperative Hyperglycemia(From initiation to termination of cardiopulmonary bypass)
- Incidence of Intraoperative Hypoglycemia(From initiation to termination of cardiopulmonary bypass)
研究者
Feilong Hei
Professor, Chief Physician, and Director of the Department of Extracorporeal Circulation and Mechanical Circulatory Support
Beijing Anzhen Hospital
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