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

Primary Purpose

Angina Pectoris, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sham control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Angina Pectoris focused on measuring remote ischemic conditioning, orthopedic surgery, ischemic heart disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RIPC group

Control group

Arm Description

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

No remote ischemic conditioning, but blood pressure cuff applied to the upper or lower limb available

Outcomes

Primary Outcome Measures

Troponin-I

Secondary Outcome Measures

Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Acute kidney injury
Acute kidney injury determined by AKIN criteria
ST-II segment analysis by Electrocardiography
Oxygenation index (PaO2/FiO2)
Oxygenation index (PaO2/FiO2)
Oxygenation index (PaO2/FiO2)
(at PACU)
Oxygenation index (PaO2/FiO2)
length of hospital stay
length of hospital stay
length of ICU stay
length of ICU stay
Postoperative wound infection
Postoperative wound infection
Postoperative incidence of pneumonia
Postoperative incidence of pneumonia
Postoperative incidence of myocardial ischemic event
Postoperative incidence of myocardial ischemic event
Troponin-I
Troponin-I
Troponin-I
Creatinine
Creatinine
Creatinine
Creatinine

Full Information

First Posted
June 14, 2016
Last Updated
September 3, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02808936
Brief Title
The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Myocardial Infarction
Keywords
remote ischemic conditioning, orthopedic surgery, ischemic heart disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIPC group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
No remote ischemic conditioning, but blood pressure cuff applied to the upper or lower limb available
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
three cycles of ischemia (5 min) / reperfusion (5 min) of available upper or lower limb with an automated machine using blood pressure cuff
Intervention Type
Procedure
Intervention Name(s)
Sham control
Intervention Description
The patients had the same pneumatic cuff around the upper arm and similar maneuvers were performed, but pressure was not applied to the cuff.
Primary Outcome Measure Information:
Title
Troponin-I
Time Frame
postoperative day one
Secondary Outcome Measure Information:
Title
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time Frame
immediate postoperative
Title
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time Frame
postoperative day one
Title
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time Frame
postoperative day two
Title
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time Frame
postoperative day four
Title
Acute kidney injury
Description
Acute kidney injury determined by AKIN criteria
Time Frame
postoperative 48 hours
Title
ST-II segment analysis by Electrocardiography
Time Frame
every 30 minutes during surgery
Title
Oxygenation index (PaO2/FiO2)
Time Frame
5 minutes after anesthesia induction
Title
Oxygenation index (PaO2/FiO2)
Time Frame
5 minutes before the end of surgery
Title
Oxygenation index (PaO2/FiO2)
Description
(at PACU)
Time Frame
20 minutes after the end of surgery
Title
Oxygenation index (PaO2/FiO2)
Time Frame
postoperative day one
Title
length of hospital stay
Description
length of hospital stay
Time Frame
up to 24 week
Title
length of ICU stay
Description
length of ICU stay
Time Frame
up to 24 week
Title
Postoperative wound infection
Description
Postoperative wound infection
Time Frame
up to 24 week
Title
Postoperative incidence of pneumonia
Description
Postoperative incidence of pneumonia
Time Frame
up to 24 week
Title
Postoperative incidence of myocardial ischemic event
Description
Postoperative incidence of myocardial ischemic event
Time Frame
up to 24 week
Title
Troponin-I
Time Frame
immediate postoperative
Title
Troponin-I
Time Frame
Postoperative day two
Title
Troponin-I
Time Frame
Postoperative day four
Title
Creatinine
Time Frame
Immediate Postoperative
Title
Creatinine
Time Frame
Postoperative day one
Title
Creatinine
Time Frame
Postoperative day two
Title
Creatinine
Time Frame
Postoperative day four

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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