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| Name | Class |
|---|---|
| Beijing Luhe Hospital | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tight Glycemic Control Group | Active Comparator | Glycemia is controlled at 5-8 mmol/L during CPB |
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| Liberal Glycemic Control Group | Experimental | Glycemia is controlled at 11-14 mmol/L during CPB |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tight Glycemic Management Protocol | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the day of surgery up to 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative 30-day All-cause Mortality | Incidence of all-cause mortality, defined as any death occurring from the day of surgery until the 30th postoperative day, regardless of the underlying cause or mechanism of death. | From the day of surgery up to 30 days postoperatively |
| Perioperative Renal Dysfunction (CSA-AKI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feilong Hei, MD | Contact | +86 13311573372 | heifeilong@126.com |
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| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| ID | Term |
|---|---|
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Liberal Glycemic Management Protocol | Other | 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. |
|
| Short-acting Insulin | Drug | 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。 |
|
Incidence of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline criteria. The severity of AKI is graded on a scale from Stage 1 to Stage 3, where: Stage 1 is the minimum severity. Stage 3 is the maximum severity. Higher stages indicate a worse clinical outcome (more severe kidney injury). The occurrence is confirmed if a patient meets the criteria for any KDIGO stage within the 30-day postoperative period. |
| From the day of surgery up to 30 days postoperatively |
| Perioperative Myocardial Injury and Infarction (PMI) | Defined by the 4th Universal Definition of MI (2018): cTn elevation >99th percentile URL with ≥1 of: ① ischemic symptoms; ② new ST-T changes or LBBB; ③ pathological Q waves; ④ imaging evidence of new loss of viable myocardium or new regional wall motion abnormality (RWMA); ⑤ coronary thrombus via angiography/autopsy. For CABG-related MI (within 48h): In patients with normal baseline, cTn >10x 99th percentile URL plus ≥1 of: ① new pathological Q waves or LBBB; ② documented new graft or native coronary artery occlusion; ③ imaging evidence of new loss of viable myocardium or new RWMA. | From the day of surgery up to 30 days postoperatively |
| Postoperative Stroke | Defined as a new-onset intracranial cerebral infarction or hemorrhage diagnosed by non-contrast head CT scan. This includes cases with or without associated neurological symptoms and signs, such as motor/sensory deficits, facial palsy, altered consciousness, aphasia, or difficulty in language comprehension. | From the day of surgery up to 30 days postoperatively |
| Perioperative Hepatic Dysfunction | Incidence of perioperative hepatic dysfunction defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. Liver impairment is graded on a scale from Grade 1 to Grade 5, where: Grade 1 represents mild symptoms or asymptomatic conditions (minimum). Grade 5 represents death related to the adverse event (maximum). Higher grades indicate a worse clinical outcome (more severe hepatic dysfunction). Hepatic dysfunction is confirmed when the severity reaches Grade 3 or higher within the 30-day postoperative period. | From the day of surgery up to 30 days postoperatively |
| New-onset Symptomatic Respiratory Failure | Defined as postoperative mechanical ventilation duration >48 hours, or the necessity for re-intubation or tracheostomy for airway control due to respiratory function decline or suppression where spontaneous breathing is insufficient to maintain normal oxygen saturation. | From the day of surgery up to 30 days postoperatively |
| Deep Sternal Wound Infection or Mediastinitis | Defined per the US Centers for Disease Control and Prevention (CDC) criteria for deep incisional Surgical Site Infection (SSI). The infection must involve fascial or muscle layers and/or lead to unplanned readmission or reoperation due to deep-seated infection. | From the day of surgery up to 30 days postoperatively |
| New-onset Mechanical Circulatory Support | Defined as the postoperative implantation of mechanical circulatory support devices, including Intra-aortic Balloon Pump (IABP), Extracorporeal Membrane Oxygenation (ECMO), or Impella. This applies to patients requiring device insertion to maintain hemodynamic stability due to acute decline in cardiac function or circulatory autoregulation. | From the day of surgery up to 30 days postoperatively |
| New-onset Symptomatic Atrial Fibrillation | Defined as the first occurrence of AF rhythm (lasting ≥30 seconds) confirmed by ECG or continuous monitoring during or within 30 days post-surgery in patients with no prior history of AF. The episode must be accompanied by clinical symptoms such as palpitations, chest tightness, dyspnea, dizziness, or hypotension. | From the day of surgery up to 30 days postoperatively |
| New-onset In-hospital Infection | Defined as a new infection occurring ≥48 hours after admission or surgery in patients with no prior evidence of infection. Diagnosis requires at least one of: ① positive microbiological culture or radiographic evidence; ② clinical symptoms (fever, leukocytosis, local signs); ③ clinical diagnosis necessitating anti-infective therapy. Includes pneumonia, urinary tract, bloodstream, and surgical site infections. | From the day of surgery up to 30 days postoperatively |
| Duration of Postoperative Mechanical Ventilation | The time interval measured from the end of the operation to successful extubation (defined as the first instance of autonomous breathing without ventilator support for at least 24 hours). Unit of Measure: Days | From the day of surgery up to 30 days postoperatively (or until ICU discharge) |
| Length of Stay in the Intensive Care Unit (ICU) | The time interval between the end of the operation and discharge from the ICU. | From the day of surgery up to 30 days postoperatively |
| Postoperative Hospital Length of Stay | The number of days between the index operation and discharge from the hospital. | From the day of surgery up to 30 days postoperatively |
| Total Hospitalization Cost | Defined as the total medical expenditure incurred during the entire hospitalization period until discharge | From the day of surgery up to 30 days postoperatively |
| Intraoperative Glycemic Variability during CPB | The primary metric for glycemic variability is the Coefficient of Variation (CV). Other supporting metrics, including Standard Deviation (SD) and Variability Independent of the Mean (VIM), will also be calculated to provide a comprehensive assessment of glucose fluctuations. Unit of Measure: Percentage (Coefficient of Variation) | From initiation to termination of cardiopulmonary bypass |
| Time-Weighted Average (TWA) Glucose during CPB | The time-weighted average of blood glucose concentrations to reflect the overall glucose exposure during the procedure. Unit of Measure: mmol/L | From initiation to termination of cardiopulmonary bypass |
| Duration of Intraoperative Hyperglycemia | Total cumulative time during which the patient's blood glucose levels are measured above 14.0 mmol/L. Unit of Measure: Minutes | From initiation to termination of cardiopulmonary bypass |
| Incidence of Intraoperative Hypoglycemia | The proportion of participants who experience at least one blood glucose level measurement below 3.9 mmol/L (Yes/No incidence). Unit of Measure: Percentage of participants | From initiation to termination of cardiopulmonary bypass |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |