Seoul National University Hospital
Seoul, 110-744, South Korea
NCT Number: NCT00997217
Perioperative myocardial injury is a serious complication of cardiac surgery. This complication increases both mortality and morbidity of cardiac surgery. Remote ischemic preconditioning (RIPC) is the concept that brief ischemia followed by reperfusion in an organ can reduce subsequent ischemia-reperfusion injury in distant organs. Recent several clinical trials showed powerful myocardial protective effect of remote ischemic preconditioning by reducing postoperative cardiac enzymes. However, the evidence that remote ischemic preconditioning can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a multicenter randomized controlled study to evaluate that remote ischemic preconditioning can improve the outcomes of cardiac surgery.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Seoul, 110-744, South Korea
Perioperative myocardial injury is a serious complication of cardiac surgery. This complication increases both mortality and morbidity of cardiac surgery. Remote ischemic preconditioning (RIPC) is the concept that brief ischemia followed by reperfusion in an organ can reduce subsequent ischemia-reperfusion injury in distant organs. Recent several clinical trials showed powerful myocardial protective effect of remote ischemic preconditioning by reducing postoperative cardiac enzymes. However, the evidence that remote ischemic preconditioning can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a multicenter randomized controlled study to evaluate that remote ischemic preconditioning can improve the outcomes of cardiac surgery.
Purpose:
The purpose of this study is to examine if remote ischemic preconditioning can decrease the mortality and fatal postoperative complications in patients undergoing cardiac surgery. The effect will be assessed by mortality, severe morbidities and duration of hospital stay.
Methods:
Study patients will be randomized to cardiac surgery with RIPC or conventional cardiac surgery in two cardiac surgical centers (Seoul National University Hospital and Asan Medical Center). Remote ischemic preconditioning consists of four 5 min cycles of upper limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg. RIPC is performed twice: before and after the coronary anastomosis in off-pump coronary bypass graft surgery; or before and after the cardiopulmonary bypass in the cardiac valve surgery.
Primary study outcome is in-hospital death within 30 postoperative days and fatal postoperative complications such as myocardial infarction, stoke, respiratory failure, renal failure, cardiogenic shock and gastrointestinal complications. Secondary outcomes include the length of intensive care unit (ICU) stay and hospital stay.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
remote ischemic preconditioning (4 x 5 min upper limb ischemia with pneumatic cuff up to 200 mmHg with an intervening 5 min reperfusion; 2 cycles; before and after the coronary anastomosis or cardiopulmonary bypass)
Other names: Blood pressure pneumatic cuff
Time frame: Postoperative 30 days
Time frame: Postoperative 30 days
Time frame: Postoperative 30 days
Time frame: Postoperative 30 days
Time frame: Postoperative 30 days
Time frame: Postoperative 30 days
Time frame: Postoperative 30 days
Time frame: Postoperative 30 days
Time frame: Postoperative 3 months
Time frame: Postoperative 3 months
Seoul National University Hospital
Other
The Effect of Remote Ischemic Preconditioning on Mortality and Morbidity in Cardiac Surgery: a Randomized Controlled Trial
Acronym: RIPC
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