The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery (RIPC-Angina)

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Angina Pectoris
• Intervention / Treatment: Procedure: Remote ischemic preconditioning; Procedure: Sham control

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 3, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: ischemic heart disease; remote ischemic conditioning; orthopedic surgery
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris
• Other Study ID Numbers: 1604-079-754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO