The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Troponin-I
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Troponin-I
Time Frame: postoperative day one
Secondary Outcomes
- Creatinine(Postoperative day four)
- Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)(postoperative day four)
- Acute kidney injury(postoperative 48 hours)
- ST-II segment analysis by Electrocardiography(every 30 minutes during surgery)
- Oxygenation index (PaO2/FiO2)(postoperative day one)
- length of hospital stay(up to 24 week)
- length of ICU stay(up to 24 week)
- Postoperative wound infection(up to 24 week)
- Postoperative incidence of pneumonia(up to 24 week)
- Postoperative incidence of myocardial ischemic event(up to 24 week)
- Troponin-I(Postoperative day four)
Investigators
Won Ho Kim, MD
Clinical Associate Professor
Seoul National University Hospital