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Completed

NCT Number: NCT02808936

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Troponin-I

    Time frame: postoperative day one

Secondary outcomes

  1. Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)

    Time frame: immediate postoperative

  2. Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)

    Time frame: postoperative day one

  3. Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)

    Time frame: postoperative day two

  4. Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)

    Time frame: postoperative day four

  5. Acute kidney injury

    Time frame: postoperative 48 hours

    Acute kidney injury determined by AKIN criteria

  6. ST-II segment analysis by Electrocardiography

    Time frame: every 30 minutes during surgery

  7. Oxygenation index (PaO2/FiO2)

    Time frame: 5 minutes after anesthesia induction

  8. Oxygenation index (PaO2/FiO2)

    Time frame: 5 minutes before the end of surgery

  9. Oxygenation index (PaO2/FiO2)

    Time frame: 20 minutes after the end of surgery

    (at PACU)

  10. Oxygenation index (PaO2/FiO2)

    Time frame: postoperative day one

  11. length of hospital stay

    Time frame: up to 24 week

    length of hospital stay

  12. length of ICU stay

    Time frame: up to 24 week

    length of ICU stay

  13. Postoperative wound infection

    Time frame: up to 24 week

    Postoperative wound infection

  14. Postoperative incidence of pneumonia

    Time frame: up to 24 week

    Postoperative incidence of pneumonia

  15. Postoperative incidence of myocardial ischemic event

    Time frame: up to 24 week

    Postoperative incidence of myocardial ischemic event

  16. Troponin-I

    Time frame: immediate postoperative

  17. Troponin-I

    Time frame: Postoperative day two

  18. Troponin-I

    Time frame: Postoperative day four

  19. Creatinine

    Time frame: Immediate Postoperative

  20. Creatinine

    Time frame: Postoperative day one

  21. Creatinine

    Time frame: Postoperative day two

  22. Creatinine

    Time frame: Postoperative day four

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: RIPC-Angina

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 22, 2016
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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