RecruitingNot ApplicableNCT06977230

Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG

The Effect of Remote Ischemic Preconditioning on Myocardial Protection in Patients With Type 2 Diabetes Mellitus Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Double-Blind Study


Sponsor

Muğla Sıtkı Koçman University

Enrollment

60 participants

Start Date

May 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized, double-blind, prospective clinical trial aims to investigate the effect of remote ischemic preconditioning (RIPC) on myocardial protection in patients with type 2 diabetes mellitus undergoing elective coronary artery bypass graft (CABG) surgery. Perioperative myocardial injury remains a significant concern during CABG, particularly in high-risk patients such as those with diabetes. RIPC is a low-cost, non-invasive intervention that may reduce myocardial damage by enhancing ischemic tolerance through intermittent limb ischemia. Sixty patients aged 40-85 years with type 2 diabetes scheduled for isolated CABG will be randomized to either receive RIPC or standard care. RIPC will be applied through five cycles of upper limb cuff inflation and deflation prior to sternotomy. High-sensitivity troponin T levels will be measured at 24, 48, and 72 hours postoperatively to assess myocardial injury. Secondary outcomes include acute kidney injury (KDIGO classification), maximum vasoactive-inotropic score (VIS) during the first 72 postoperative hours, ICU and hospital length of stay. This study will provide insight into the cardioprotective role of RIPC in diabetic patients undergoing cardiac surgery.


Eligibility

Min Age: 45 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a technique called remote ischemic preconditioning (RIPC) in people with type 2 diabetes who are having heart bypass surgery (CABG). RIPC involves briefly limiting blood flow to the arm using a blood pressure cuff before surgery, with the goal of protecting the heart from damage during the operation. **You may be eligible if...** - You have type 2 diabetes and are on medication for it - You are scheduled for planned (non-emergency) heart bypass surgery - You are between 40 and 85 years old **You may NOT be eligible if...** - Your bypass surgery is an emergency - You are having a second bypass surgery (revision) - Your heart's pumping function is severely reduced (ejection fraction below 40%) - You have had a cardiac arrest or cardiogenic shock - You are pregnant - You have significant circulation problems in your arms - You have severe liver or kidney problems - You take glibenclamide or nicorandil (medications that may interfere with the preconditioning effect) - You have asthma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERemote Ischemic Preconditioning

Remote ischemic preconditioning (RIPC) will be performed after anesthesia induction and before surgical incision. A standard blood pressure cuff will be placed on the upper limb (without arterial cannulation), inflated to 200 mmHg for 5 minutes, and then deflated for 5 minutes. This cycle will be repeated five times prior to sternotomy. The procedure will be carried out under general anesthesia, ensuring patient blinding. No pharmacological agents are involved in this intervention


Locations(2)

Mugla Training and Research Hospital

Muğla, Turkey (Türkiye)

Mugla Training and Research Hospital

Muğla, Turkey (Türkiye)

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NCT06977230


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