Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorMuğla Sıtkı Koçman University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Remote Ischemic Preconditioning
Procedure/SurgeryRemote 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Remote Ischemic Preconditioning GroupActive comparator 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
24 hours after surgerySecondary outcomes
1
Incidence and severity of acute kidney injury
Time frame
Within 72 hours postoperatively2
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.
Time frame
48 hours after surgery3
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.
Time frame
72 hours after surgery4
Maximum vasoactive-inotropic score (VIS) in the first 72 hours postoperatively
Time frame
0-72 hours after surgeryOther outcomes
1
Correlation between high-sensitivity Troponin T levels and maximum vasoactive-inotropic score (VIS)
Time frame
Within 72 hours after surgery2
Correlation between Troponin T levels and duration of ICU stay
Time frame
From ICU admission through ICU discharge3
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.
Time frame
Intraoperative period and up to 72 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov