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

Myocardial Infarction Clinical Trial

— RIPC-Angina  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808936
• Other study ID #: 1604-079-754
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: September 3, 2017
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

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 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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