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

NCT02808936 | Completed DMC

• 1 other identifier: 1604-079-754
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina Pectoris; Myocardial Infarction

Keywords

remote ischemic conditioning; orthopedic surgery; ischemic heart disease

Outcome Measures

Primary Outcomes (1)

• Troponin-I

  postoperative day one

Secondary Outcomes (22)

• 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

  postoperative 48 hours

Study Arms (2)

RIPC group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Procedure: Sham control

Interventions

Remote ischemic preconditioning PROCEDURE

three cycles of ischemia (5 min) / reperfusion (5 min) of available upper or lower limb with an automated machine using blood pressure cuff

RIPC group

Sham control PROCEDURE

The patients had the same pneumatic cuff around the upper arm and similar maneuvers were performed, but pressure was not applied to the cuff.

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Peripheral vascular disease involving upper or lower extremity
• Orthopedic surgery which uses the tourniquet

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Angina Pectoris; Myocardial Infarction; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 22, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)