Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG

Muğla Sıtkı Koçman University

Status: Enrolling

Conditions: Remote Ischaemic Conditioning; Diabetes Mellitus; Coronary Artery Bypass

Treatments: Procedure: Remote Ischemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06977230

RIPC-T2DM-CABG-2025

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Remote Ischemic Preconditioning Group

Active Comparator group

Description:

Patients randomized to this group will receive remote ischemic preconditioning (RIPC) prior to sternotomy. RIPC will be performed by inflating a blood pressure cuff on the upper limb to 200 mmHg for 5 minutes, followed by 5 minutes of deflation. This cycle will be repeated 5 times before the start of cardiopulmonary bypass.Assigned Intervention: Remote Ischemic Preconditioning

Treatment:

Procedure: Remote Ischemic Preconditioning

Control Group

No Intervention group

Description:

Patients in the control group will undergo standard anesthetic and surgical care without the application of remote ischemic preconditioning.