Glycemic Management During CPB in Elderly Diabetic Cardiac Surgery
Conditions
Keywords
different glycemic target during CPB, elderly diabetes, cardiac bypass surgery, clinical outcome
Brief 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
Interventions
OTHERTight 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.
OTHERLiberal 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.
DRUGShort-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。
Sponsors
Beijing Anzhen Hospital
Beijing Luhe Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: age ≥ 60 years old. 2. 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. 3. Procedure: Undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB). 4. 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). 5. Informed Consent: Willing and able to provide written informed consent.
Exclusion criteria
1. Surgical Factors: Emergency surgery, redo sternotomy, heart transplantation, or left ventricular assist device (LVAD) implantation. 2. Organ Dysfunction: Severe hepatic insufficiency (Child-Pugh Class C) or pre-existing dependence on renal replacement therapy (RRT). 3. Neurological Status: History of severe disabling stroke (mRS \> 3) or dementia that prevents meaningful neurological assessment. 4. 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. 5. Glycemic Baseline: Preoperative HbA1c \> 10%. 6. Pregnancy/Lactation: Women who are currently pregnant or breastfeeding. 7. Life Expectancy: Terminal illness with an expected survival of less than 3 months. 8. Communication Barriers: Inability to effectively communicate or provide informed consent due to mental, legal, or other disabilities. 9. Co-enrollment: Concurrent participation in another perioperative interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of major adverse cardio-cerebro-renal and vascular events (MACCE+) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative 30-day All-cause Mortality | From the day of surgery up to 30 days postoperatively | 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. |
| Perioperative Renal Dysfunction (CSA-AKI) | From the day of surgery up to 30 days postoperatively | 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. |
| Perioperative Myocardial Injury and Infarction (PMI) | From the day of surgery up to 30 days postoperatively | 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. |
| Postoperative Stroke | From the day of surgery up to 30 days postoperatively | 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. |
| Perioperative Hepatic Dysfunction | From the day of surgery up to 30 days postoperatively | 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. |
| New-onset Symptomatic Respiratory Failure | From the day of surgery up to 30 days postoperatively | 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. |
| Deep Sternal Wound Infection or Mediastinitis | From the day of surgery up to 30 days postoperatively | 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. |
| New-onset Mechanical Circulatory Support | From the day of surgery up to 30 days postoperatively | 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. |
| New-onset Symptomatic Atrial Fibrillation | From the day of surgery up to 30 days postoperatively | 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. |
| New-onset In-hospital Infection | From the day of surgery up to 30 days postoperatively | 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. |
| Duration of Postoperative Mechanical Ventilation | From the day of surgery up to 30 days postoperatively (or until ICU discharge) | 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 |
| Length of Stay in the Intensive Care Unit (ICU) | From the day of surgery up to 30 days postoperatively | The time interval between the end of the operation and discharge from the ICU. |
| Postoperative Hospital Length of Stay | From the day of surgery up to 30 days postoperatively | The number of days between the index operation and discharge from the hospital. |
| Total Hospitalization Cost | From the day of surgery up to 30 days postoperatively | Defined as the total medical expenditure incurred during the entire hospitalization period until discharge |
| Intraoperative Glycemic Variability during CPB | From initiation to termination of cardiopulmonary bypass | 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) |
| Time-Weighted Average (TWA) Glucose during CPB | From initiation to termination of cardiopulmonary bypass | The time-weighted average of blood glucose concentrations to reflect the overall glucose exposure during the procedure. Unit of Measure: mmol/L |
| Duration of Intraoperative Hyperglycemia | From initiation to termination of cardiopulmonary bypass | Total cumulative time during which the patient's blood glucose levels are measured above 14.0 mmol/L. Unit of Measure: Minutes |
| Incidence of Intraoperative Hypoglycemia | From initiation to termination of cardiopulmonary bypass | 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 |
Contacts
CONTACTFeilong Hei, MD
Outcome results
None listed