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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischemic Preconditioning Group | Active Comparator | 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 |
|
| Control Group | No Intervention | Patients in the control group will undergo standard anesthetic and surgical care without the application of remote ischemic preconditioning. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischemic Preconditioning | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of acute kidney injury | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between high-sensitivity Troponin T levels and maximum vasoactive-inotropic score (VIS) | Within 72 hours after surgery | |
| Correlation between Troponin T levels and duration of ICU stay | From ICU admission through ICU discharge |
Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melike Korkmaz Toker, Associate Professor | Contact | 00905054747098 | meltoker@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mugla Training and Research Hospital | Not yet recruiting | Muğla | 48000 | Turkey (Türkiye) |
Individual participant data (IPD) may not be shared due to institutional policies and ethical considerations regarding patient confidentiality. The study protocol does not include provisions for public data sharing, and participants dmay not provide consent for external access to their personal health data.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D017202 | Myocardial Ischemia |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| 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. | 72 hours after surgery |
| Maximum vasoactive-inotropic score (VIS) in the first 72 hours postoperatively | 0-72 hours after surgery |
| Length of ICU and hospital stay | From ICU admission to ICU discharge and from hospital admission to hospital discharge, assessed up to 60 days |
| Correlation between intraoperative maximum vasoactive-inotropic score (VIS) and postoperative myocardial injury | 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. | Intraoperative period and up to 72 hours postoperatively |
| Mugla Training and Research Hospital | Recruiting | Muğla | Turkey (Türkiye) |
|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |