Coronary Artery Bypass, Diabetes Mellitus, Remote Ischaemic Conditioning
Conditions
Keywords
High sensitive Troponin T, Diabetes mellitus Type 2, Coronary Artery Bypass, Myocardial Ischemia, Remote Ischemic Conditioning, Acute Kidney Injury, Cardioprotection
Brief summary
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
PROCEDURERemote 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
Sponsors
Muğla Sıtkı Koçman University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative 24-hour high-sensitivity Troponin T level | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU and hospital stay | From ICU admission to ICU discharge and from hospital admission to hospital discharge, assessed up to 60 days | — |
| Postoperative 48-hour high-sensitivity Troponin T level | 48 hours after surgery | 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. |
| Postoperative 72-hour high-sensitivity Troponin T level | 72 hours after surgery | 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. |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between intraoperative maximum vasoactive-inotropic score (VIS) and postoperative myocardial injury | Intraoperative period and up to 72 hours postoperatively | The correlation between the maximum intraoperative VIS score and high-sensitivity Troponin T (hs-TnT) levels measured at 24, 48, and 72 hours postoperatively will be assessed. This outcome will evaluate whether intraoperative hemodynamic support requirement is associated with subsequent myocardial injury. |
| Correlation between Troponin T levels and duration of ICU stay | From ICU admission through ICU discharge | — |
| Correlation between high-sensitivity Troponin T levels and maximum vasoactive-inotropic score (VIS) | Within 72 hours after surgery | — |
Countries
Turkey (Türkiye)
Contacts
Primary ContactMelike Korkmaz Toker, Associate Professor
Outcome results
None listed