The Effect of Remote Ischemic Preconditioning on Myocardial Protection in Patients With Type 2 Diabetes Mellitus Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Double-Blind Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Mugla Training and Research Hospital
NOT_YET_RECRUITING
Mugla
Mugla Training and Research Hospital
RECRUITING
Mugla
Contact Information
Primary
Melike Korkmaz Toker, Associate Professor
meltoker@gmail.com
00905054747098
Time Frame
Start Date: 2025-05-26
Estimated Completion Date: 2025-09-15
Participants
Target number of participants: 60
Treatments
Active_comparator: Remote Ischemic Preconditioning Group
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
No_intervention: Control Group
Patients in the control group will undergo standard anesthetic and surgical care without the application of remote ischemic preconditioning.
Sponsors
Leads: Muğla Sıtkı Koçman University

This content was sourced from clinicaltrials.gov