The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery (RIPC)
|Myocardium; Injury Cardiac Surgical Procedures||Procedure: remote ischemic preconditioning||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Official Title:||The Effect of Remote Ischemic Preconditioning on Mortality and Morbidity in Cardiac Surgery: a Randomized Controlled Trial|
- In-hospital death [ Time Frame: Postoperative 30 days ]
- Myocardial infarction [ Time Frame: Postoperative 30 days ]
- Stroke [ Time Frame: Postoperative 30 days ]
- Respiratory failure [ Time Frame: Postoperative 30 days ]
- Renal dysfunction [ Time Frame: Postoperative 30 days ]
- Renal failure [ Time Frame: Postoperative 30 days ]
- Cardiogenic shock [ Time Frame: Postoperative 30 days ]
- Gastrointestinal complication [ Time Frame: Postoperative 30 days ]
- Length of ICU stay [ Time Frame: Postoperative 3 months ]
- Length of postoperative hospital stay [ Time Frame: Postoperative 3 months ]
|Study Start Date:||October 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Procedure: remote ischemic preconditioning
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997217
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Study Director:||YunSeok Jeon, professor||Department of Anesthesiology and Pain Medicine, SNUH|