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 range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.