The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery

Study Overview
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Brief Summary
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The investigators attempt to investigate the organ protective effect of remote ischemic conditioning in patients undergoing non-cardiac surgery with history of ischemic heart disease.

Detailed Description
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When adult patients with ischemic heart disease undergo non-cardiac surgery, perioperative ischemic complication may occur. These morbidity results in poor clinical outcomes. The incidence of perioperative myocardial ischemic event has been reported to be up to 19.7%. Remote ischemic preconditioning (RIPC) is a concept that a brief ischemic reperfusion of upper or lower extremity can transfer protection to the other vital organs from sustained ischemic reperfusion injury. Although RIPC is extensively studied in high risk cardiovascular surgery, it has not been tested in a non-cardiac surgery patients with a history of ischemic heart disease. Major organ injury including heart, lung and kidney will be evaluated in this randomized controlled trial.

Official Title
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The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery - a Randomized Controlled Trial

Conditions
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Angina Pectoris, Myocardial Infarction

Intervention / Treatment
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* Procedure: Remote ischemic preconditioning
* Procedure: Sham control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults patients who undergo orthopedic surgery with duration of longer than one hour Patients with a history of ischemic heart disease (stable or unstable angina, myocardial infarction) American Society of Anesthesiology (ASA) Physical Status Classification of 1, 2, or 3 Exclusion Criteria: Peripheral vascular disease involving upper or lower extremity Orthopedic surgery which uses the tourniquet

Ages Eligible for Study
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Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC group<br>remote ischemic conditioning group with three cycles of ischemia (5 min) / reperfusion (5 min) of upper or lower limb available with automated RIPC machine using blood pressure cuff | Procedure: Remote ischemic preconditioning<br>* three cycles of ischemia (5 min) / reperfusion (5 min) of available upper or lower limb with an automated machine using blood pressure cuff<br>|
| Sham Comparator: Control group<br>No remote ischemic conditioning, but blood pressure cuff applied to the upper or lower limb available | Procedure: Sham control<br>* The patients had the same pneumatic cuff around the upper arm and similar maneuvers were performed, but pressure was not applied to the cuff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin-I |  | postoperative day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band) |  | immediate postoperative | 
| Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band) |  | postoperative day one | 
| Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band) |  | postoperative day two | 
| Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band) |  | postoperative day four | 
| Acute kidney injury | Acute kidney injury determined by AKIN criteria | postoperative 48 hours | 
| ST-II segment analysis by Electrocardiography |  | every 30 minutes during surgery | 
| Oxygenation index (PaO2/FiO2) |  | 5 minutes after anesthesia induction | 
| Oxygenation index (PaO2/FiO2) |  | 5 minutes before the end of surgery | 
| Oxygenation index (PaO2/FiO2) | (at PACU) | 20 minutes after the end of surgery | 
| Oxygenation index (PaO2/FiO2) |  | postoperative day one | 
| length of hospital stay | length of hospital stay | up to 24 week | 
| length of ICU stay | length of ICU stay | up to 24 week | 
| Postoperative wound infection | Postoperative wound infection | up to 24 week | 
| Postoperative incidence of pneumonia | Postoperative incidence of pneumonia | up to 24 week | 
| Postoperative incidence of myocardial ischemic event | Postoperative incidence of myocardial ischemic event | up to 24 week | 
| Troponin-I |  | immediate postoperative | 
| Troponin-I |  | Postoperative day two | 
| Troponin-I |  | Postoperative day four | 
| Creatinine |  | Immediate Postoperative | 
| Creatinine |  | Postoperative day one | 
| Creatinine |  | Postoperative day two | 
| Creatinine |  | Postoperative day four | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischemic conditioning, orthopedic surgery, ischemic heart disease