Recruiting

Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG

ClinicalTrials.gov IDNCT06977230

PhaseNA

Enrollment60

SponsorMuğla Sıtkı Koçman University

Age45 Years

SexALL

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Conditions studied

Diabetes Mellitus, Coronary Artery Bypass, Remote Ischaemic Conditioning

About this study

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.

Interventions

Procedure: Remote 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

Primary outcomes

Postoperative 24-hour high-sensitivity Troponin T level (24 hours after surgery)

Eligibility information

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

Study locations

Mugla Training and Research Hospital, Muğla, 48000 Turkey (Türkiye)
Mugla Training and Research Hospital, Muğla, Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.