The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery
Condition: Myocardium; Injury; Cardiac Surgical Procedures
MeSH terms: Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): remote ischemic preconditioning
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): Blood pressure pneumatic cuff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: RIPC; cardiac surgery; ischemic preconditioning; cardiac surgical procedures