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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative 24-hour high-sensitivity Troponin T level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes mellitus and receiving medical treatment
- •Scheduled for isolated elective coronary artery bypass graft (CABG) surgery
- •American Society of Anesthesiologists (ASA) physical status class III or IV
- •Age between 40 and 85 years
排除标准
- •Emergency CABG surgery Reoperation (revision surgery) Left ventricular ejection fraction (LVEF) < 40% History of cardiac arrest or cardiogenic shock Pregnancy Clinically significant peripheral arterial disease affecting the upper limbs Hepatic dysfunction (bilirubin > 20 μmol/L or INR > 2.0) Renal failure (eGFR < 20 mL/min/1.73 m²) Ongoing treatment with glibenclamide or nicorandil (agents known to interfere with ischemic preconditioning mechanisms) Asthma
结局指标
主要结局
Postoperative 24-hour high-sensitivity Troponin T level
时间窗: 24 hours after surgery
Myocardial injury will be assessed by measuring high-sensitivity cardiac Troponin T (hs-TnT) levels at 24 hours after coronary artery bypass graft (CABG) surgery. Blood samples will be collected at the 24th postoperative hour and analyzed using a standardized high-sensitivity Troponin T assay (reference range: 0-14 ng/L). The primary endpoint will be the mean hs-TnT concentration in each group.
次要结局
- Postoperative 48-hour high-sensitivity Troponin T level(48 hours after surgery)
- Postoperative 72-hour high-sensitivity Troponin T level(72 hours after surgery)
- Maximum vasoactive-inotropic score (VIS) in the first 72 hours postoperatively(0-72 hours after surgery)
- Incidence and severity of acute kidney injury(Within 72 hours postoperatively)
- Length of ICU and hospital stay(From ICU admission to ICU discharge and from hospital admission to hospital discharge, assessed up to 60 days)
研究者
Melike Korkmaz Toker
Associate Professor
Muğla Sıtkı Koçman University