The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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The Effect of Remote Ischemic Preconditioning on Mortality and Morbidity in Cardiac Surgery: a Randomized Controlled Trial

Conditions
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Myocardium; Injury, Cardiac Surgical Procedures

Intervention / Treatment
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* Procedure: remote ischemic preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients undergoing cardiac surgery Exclusion Criteria: emergent operation preoperative use of inotropics or mechanical assist device, left ventricular ejection fraction less than 30%, severe liver, renal and pulmonary disease, recent myocardial infarction (within 7 days), recent systemic infection or sepsis (within 7 days) peripheral vascular disease affecting upper limbs amputation of the upper limbs major combined operation such as aortic surgery or carotid endarterectomy descending thoracic aortic surgery rare surgeries; cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, etc

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: remote ischemic preconditioning|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)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay |  | Postoperative 3 months | 
| Length of postoperative hospital stay |  | Postoperative 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RIPC, cardiac surgery, ischemic preconditioning, cardiac surgical procedures