Clinical trial NCT02808936: The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery
Official title: The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina Pectoris
Myocardial Infarction
Keywords: remote ischemic conditioning
orthopedic surgery
ischemic heart disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Troponin-I
timeFrame: postoperative day one
Secondary outcomes:
measure: Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
timeFrame: immediate postoperative
measure: Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
timeFrame: postoperative day one
measure: Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
timeFrame: postoperative day two
measure: Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
timeFrame: postoperative day four
measure: Acute kidney injury
timeFrame: postoperative 48 hours
measure: ST-II segment analysis by Electrocardiography
timeFrame: every 30 minutes during surgery
measure: Oxygenation index (PaO2/FiO2)
timeFrame: 5 minutes after anesthesia induction
measure: Oxygenation index (PaO2/FiO2)
timeFrame: 5 minutes before the end of surgery
measure: Oxygenation index (PaO2/FiO2)
timeFrame: 20 minutes after the end of surgery
measure: Oxygenation index (PaO2/FiO2)
timeFrame: postoperative day one
measure: length of hospital stay
timeFrame: up to 24 week
measure: length of ICU stay
timeFrame: up to 24 week
measure: Postoperative wound infection
timeFrame: up to 24 week
measure: Postoperative incidence of pneumonia
timeFrame: up to 24 week
measure: Postoperative incidence of myocardial ischemic event
timeFrame: up to 24 week
measure: Troponin-I
timeFrame: immediate postoperative
measure: Troponin-I
timeFrame: Postoperative day two
measure: Troponin-I
timeFrame: Postoperative day four
measure: Creatinine
timeFrame: Immediate Postoperative
measure: Creatinine
timeFrame: Postoperative day one
measure: Creatinine
timeFrame: Postoperative day two
measure: Creatinine
timeFrame: Postoperative day four
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: