Glycemic Targets During CPB in Elderly Diabetes (NCT07485101) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Glycemic Targets During CPB in Elderly Diabetes
3,000 participantsStarted 2026-04-01
Plain-language 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
Who can participate
Age range60 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Composite of major adverse cardio-cerebro-renal and vascular events (MACCE+)
Timeframe: From the day of surgery up to 30 days postoperatively
✕. 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.