Glycemic Targets During CPB in Elderly Diabetes

Официальное название

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

Обзор

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

Вмешательства

• Другое 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.
• Другое 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.
• Препарат 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。

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07485101 · TBD123456789

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗