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

Not Applicable

Completed

• Conditions: Myocardial Infarction; Angina Pectoris
• Interventions: Procedure: Remote ischemic preconditioning; Procedure: Sham control

• Registration Number: NCT02808936
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-22
• Primary Completion: 2017-04
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-03
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC group	Remote ischemic preconditioning	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
Control group	Sham control	No remote ischemic conditioning, but blood pressure cuff applied to the upper or lower limb available

Primary Outcome Measures

Name	Time	Method
Troponin-I	postoperative day one

Secondary Outcome Measures

Name	Time	Method
Creatinine	Postoperative day four
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)	postoperative day four
Acute kidney injury	postoperative 48 hours	Acute kidney injury determined by AKIN criteria
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 hospital stay
length of ICU stay	up to 24 week	length of ICU stay
Postoperative wound infection	up to 24 week	Postoperative wound infection
Postoperative incidence of pneumonia	up to 24 week	Postoperative incidence of pneumonia
Postoperative incidence of myocardial ischemic event	up to 24 week	Postoperative incidence of myocardial ischemic event
Troponin-I	Postoperative day four

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of