Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG

Muğla Sıtkı Koçman University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus Coronary Artery Bypass

Interventions

Remote Ischemic PreconditioningPROCEDURE

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: 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

Outcomes

Primary Outcomes

Postoperative 24-hour high-sensitivity Troponin T level

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.

Time frame: 24 hours after surgery

Secondary Outcomes

Incidence and severity of acute kidney injury

Time frame: Within 72 hours postoperatively

Postoperative 48-hour high-sensitivity Troponin T level

Myocardial injury will be assessed by measuring high-sensitivity cardiac Troponin T (hs-TnT) levels at 48 hours after coronary artery bypass graft (CABG) surgery. Blood samples will be collected at the 48th 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.

Time frame: 48 hours after surgery

Postoperative 72-hour high-sensitivity Troponin T level

Myocardial injury will be assessed by measuring high-sensitivity cardiac Troponin T (hs-TnT) levels at 72 hours after coronary artery bypass graft (CABG) surgery. Blood samples will be collected at the 72th 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.

Time frame: 72 hours after surgery

Maximum vasoactive-inotropic score (VIS) in the first 72 hours postoperatively

Time frame: 0-72 hours after surgery

Length of ICU and hospital stay

Time frame: From ICU admission to ICU discharge and from hospital admission to hospital discharge, assessed up to 60 days