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Glycemic Targets During CPB in Elderly Diabetes

NCT07485101 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-03-20

No results posted yet for this study

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

Conditions

  • Glycemic Management During CPB in Elderly Diabetic Cardiac Surgery

Interventions

OTHER

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.

OTHER

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.

DRUG

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。

Sponsors & Collaborators

  • Beijing Luhe Hospital

    collaborator OTHER

  • Beijing Anzhen Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-04-30
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485101 on ClinicalTrials.gov