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Glycemic Management During CPB in Elderly Diabetic Cardiac SurgeryNCT07485101

Glycemic Targets During CPB in Elderly Diabetes

A study testing Tight Glycemic Management Protocol, Liberal Glycemic Management Protocol and Short-acting Insulin in people with Glycemic Management During CPB in Elderly Diabetic Cardiac Surgery, run by Beijing Anzhen Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Tight Glycemic Management Protocol, Liberal Glycemic Management Protocol and Short-acting Insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
No sites listed yet
Study dates
1 Apr 2026to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Feilong Hei, MD contact

+86 13311573372

heifeilong@126.com

About this study

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

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?
Read more

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
Being tested
Tight Glycemic Management Protocol, Liberal Glycemic Management Protocol, Short-acting Insulin
Keywords
different glycemic target during CPB, elderly diabetes, cardiac bypass surgery, clinical outcome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tight Glycemic Management ProtocolOther

    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.

  • Liberal Glycemic Management ProtocolOther

    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 InsulinDrug

    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。

Study groups in NCT07485101
Study groupRoleWhat they receive
Tight Glycemic Control GroupActive comparatorGlycemia is controlled at 5-8 mmol/L during CPB
Receives: Other: Tight Glycemic Management Protocol; Drug: Short-acting Insulin
Liberal Glycemic Control GroupExperimentalGlycemia is controlled at 11-14 mmol/L during CPB
Receives: Other: Liberal Glycemic Management Protocol; Drug: Short-acting Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From the day of surgery up to 30 days postoperatively

Secondary outcomes (18)
  1. 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.

    Measured: From the day of surgery up to 30 days postoperatively

  2. Perioperative Renal Dysfunction (CSA-AKI)

    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.

    Measured: From the day of surgery up to 30 days postoperatively

  3. 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.

    Measured: From the day of surgery up to 30 days postoperatively

  4. 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.

    Measured: From the day of surgery up to 30 days postoperatively

  5. 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.

    Measured: From the day of surgery up to 30 days postoperatively

  6. 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.

    Measured: From the day of surgery up to 30 days postoperatively

  7. 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.

    Measured: From the day of surgery up to 30 days postoperatively

  8. 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.

    Measured: From the day of surgery up to 30 days postoperatively

  9. 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.

    Measured: From the day of surgery up to 30 days postoperatively

  10. 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.

    Measured: From the day of surgery up to 30 days postoperatively

  11. 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

    Measured: From the day of surgery up to 30 days postoperatively (or until ICU discharge)

  12. Length of Stay in the Intensive Care Unit (ICU)

    The time interval between the end of the operation and discharge from the ICU.

    Measured: From the day of surgery up to 30 days postoperatively

  13. Postoperative Hospital Length of Stay

    The number of days between the index operation and discharge from the hospital.

    Measured: From the day of surgery up to 30 days postoperatively

  14. Total Hospitalization Cost

    Defined as the total medical expenditure incurred during the entire hospitalization period until discharge

    Measured: From the day of surgery up to 30 days postoperatively

  15. 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)

    Measured: From initiation to termination of cardiopulmonary bypass

  16. 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

    Measured: From initiation to termination of cardiopulmonary bypass

  17. 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

    Measured: From initiation to termination of cardiopulmonary bypass

  18. 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

    Measured: From initiation to termination of cardiopulmonary bypass

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07485101
Sponsor's protocol ID
TBD123456789
Status last verified
Mar 2026
First submitted
11 Mar 2026
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Tight Glycemic Management Protocol, Liberal Glycemic Management Protocol and Short-acting Insulin in people with Glycemic Management During CPB in Elderly Diabetic Cardiac Surgery, run by Beijing Anzhen Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Feilong Hei, MD (+86 13311573372, heifeilong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of major adverse cardio-cerebro-renal and vascular events (MACCE+) (time frame: From the day of surgery up to 30 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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