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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote ischemic preconditioning | Procedure | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital death | Postoperative 30 days | |
| Myocardial infarction | Postoperative 30 days | |
| Stroke | Postoperative 30 days | |
| Respiratory failure | Postoperative 30 days | |
| Renal dysfunction | Postoperative 30 days | |
| Renal failure | Postoperative 30 days | |
| Cardiogenic shock | Postoperative 30 days | |
| Gastrointestinal complication | Postoperative 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU stay | Postoperative 3 months | |
| Length of postoperative hospital stay | Postoperative 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YunSeok Jeon, professor | Department of Anesthesiology and Pain Medicine, SNUH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28043669 | Derived | Cho YJ, Lee EH, Lee K, Kim TK, Hong DM, Chin JH, Choi DK, Bahk JH, Sim JY, Choi IC, Jeon Y. Long-term clinical outcomes of Remote Ischemic Preconditioning and Postconditioning Outcome (RISPO) trial in patients undergoing cardiac surgery. Int J Cardiol. 2017 Mar 15;231:84-89. doi: 10.1016/j.ijcard.2016.12.146. Epub 2016 Dec 23. | |
| 24014392 |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Hong DM, Lee EH, Kim HJ, Min JJ, Chin JH, Choi DK, Bahk JH, Sim JY, Choi IC, Jeon Y. Does remote ischaemic preconditioning with postconditioning improve clinical outcomes of patients undergoing cardiac surgery? Remote Ischaemic Preconditioning with Postconditioning Outcome Trial. Eur Heart J. 2014 Jan;35(3):176-83. doi: 10.1093/eurheartj/eht346. Epub 2013 Sep 7. |