This study evaluates the addition of remote ischemic preconditioning and postconditioning to standard myocardial protection protocol in patients submitted to off - pump coronary artery bypass grafting in a prospective, 1:1 randomized, double blind fashion. An interventional group will receive remote ischemic preconditioning 24-hours before OP-CABG, immediately before surgery and within 60 minutes following surgery by means of lower limb ischemia achieved by pressure cuff inflation, whereas control group will receive sham procedure perioperatively.
In a prospective, 1:1 randomized and double blind fashion, the study will evaluate the impact of remote ischemic preconditioning, both immediate and second window of protection (24 hours and immediately before surgery) with remote ischemic postconditiong on operative outcomes in patients submitted to coronary artery bypass grafting without use of extracorporeal circulation. Remote ischemic conditioning was found to provide protection against necrosis and apoptosis due to ischemia and reperfusion injury, a phenomenon observed during coronary artery bypass grafting. That in turn was associated with poor postoperative outcomes, predominantly poor survival. Remote ischemic preconditioning will be provided by repeated lower leg ischemia and reperfusion with pressure cuff inflation for five minutes and deflation for five minutes in three consecutive cycles. Remote ischemic preconditioning will be performed 24 hours before CABG and immediately before surgery. Remote ischemic postconditioning will be performed within 60 minutes following the last coronary artery bypass graft completion and the restoration of coronary blood flow. The study will assess clinical endpoints such as postoperative acute myocardial infarction (type 5 MI), postoperative mortality, postoperative renal failure and laboratory outcomes such as postoperative serial measurements of troponin T release or glomerular filtration rate as secondary outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Three cycles of 5 minutes of ischemia and 5 minutes of reperfusion of lower leg 24 hours, immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively.
Three cycles of 5 minutes of inflation and 5 minutes of deflation of artificial lower leg immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively.
Medinet Heart Centre
Nowa Sól, Lubusz Voivodeship, Poland
RECRUITINGPostoperative myocardial necrosis
Serial mesurements of High - Sensitive Troponin T release
Time frame: 72 hours postoperatively
Postoperative kidney injury
Serial measurements of estimated glomerular filtration rate by creatinine
Time frame: 7 days postoperatively
Perioperative mortality
30-day all cause mortality
Time frame: 30 days postoperatively
Perioperative myocardial infarction
30-day myocardial infarction
Time frame: 30 days postoperatively
Postoperative Acute Kidney Injury
Prevalence of acute kidney injury according to Society of Thoracic Surgeons definitions of outcomes.
Time frame: 30 days
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