Actively Recruiting

Phase Not Applicable
Age: 45Years - 85Years
All Genders
NCT06977230

Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG

Led by Muğla Sıtkı Koçman University · Updated on 2025-06-18

60

Participants Needed

2

Research Sites

16 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG

Who Can Participate

Age: 45Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Emergency CABG surgery
  • Reoperation (revision surgery)
  • Left ventricular ejection fraction (LVEF) less than 40%
  • History of cardiac arrest or cardiogenic shock
  • Pregnancy
  • Clinically significant peripheral arterial disease affecting the upper limbs
  • Hepatic dysfunction (bilirubin greater than 20 bcmol/L or INR greater than 2.0)
  • Renal failure (eGFR less than 20 mL/min/1.73 m8)
  • Ongoing treatment with glibenclamide or nicorandil
  • Asthma

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Mugla Training and Research Hospital

Muğla, Turkey (Türkiye), 48000

Not Yet Recruiting

2

Mugla Training and Research Hospital

Muğla, Turkey (Türkiye)

Actively Recruiting

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Research Team

M

Melike Korkmaz Toker, Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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