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NCT Number: NCT00997217

The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery

Perioperative myocardial injury is a serious complication of cardiac surgery. This complication increases both mortality and morbidity of cardiac surgery. Remote ischemic preconditioning (RIPC) is the concept that brief ischemia followed by reperfusion in an organ can reduce subsequent ischemia-reperfusion injury in distant organs. Recent several clinical trials showed powerful myocardial protective effect of remote ischemic preconditioning by reducing postoperative cardiac enzymes. However, the evidence that remote ischemic preconditioning can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a multicenter randomized controlled study to evaluate that remote ischemic preconditioning can improve the outcomes of cardiac surgery.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

Perioperative myocardial injury is a serious complication of cardiac surgery. This complication increases both mortality and morbidity of cardiac surgery. Remote ischemic preconditioning (RIPC) is the concept that brief ischemia followed by reperfusion in an organ can reduce subsequent ischemia-reperfusion injury in distant organs. Recent several clinical trials showed powerful myocardial protective effect of remote ischemic preconditioning by reducing postoperative cardiac enzymes. However, the evidence that remote ischemic preconditioning can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a multicenter randomized controlled study to evaluate that remote ischemic preconditioning can improve the outcomes of cardiac surgery.

Purpose:

The purpose of this study is to examine if remote ischemic preconditioning can decrease the mortality and fatal postoperative complications in patients undergoing cardiac surgery. The effect will be assessed by mortality, severe morbidities and duration of hospital stay.

Methods:

Study patients will be randomized to cardiac surgery with RIPC or conventional cardiac surgery in two cardiac surgical centers (Seoul National University Hospital and Asan Medical Center). Remote ischemic preconditioning consists of four 5 min cycles of upper limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg. RIPC is performed twice: before and after the coronary anastomosis in off-pump coronary bypass graft surgery; or before and after the cardiopulmonary bypass in the cardiac valve surgery.

Primary study outcome is in-hospital death within 30 postoperative days and fatal postoperative complications such as myocardial infarction, stoke, respiratory failure, renal failure, cardiogenic shock and gastrointestinal complications. Secondary outcomes include the length of intensive care unit (ICU) stay and hospital stay.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients undergoing cardiac surgery

Exclusion criteria

  • emergent operation
  • preoperative use of inotropics or mechanical assist device,
  • left ventricular ejection fraction less than 30%,
  • severe liver, renal and pulmonary disease,
  • recent myocardial infarction (within 7 days),
  • recent systemic infection or sepsis (within 7 days)
  • peripheral vascular disease affecting upper limbs
  • amputation of the upper limbs
  • major combined operation such as aortic surgery or carotid endarterectomy
  • descending thoracic aortic surgery
  • rare surgeries; cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, etc

Treatment and study plan

Remote ischemic preconditioning

Procedure

remote ischemic preconditioning (4 x 5 min upper limb ischemia with pneumatic cuff up to 200 mmHg with an intervening 5 min reperfusion; 2 cycles; before and after the coronary anastomosis or cardiopulmonary bypass)

Other names: Blood pressure pneumatic cuff

Primary outcomes

  1. In-hospital death

    Time frame: Postoperative 30 days

  2. Myocardial infarction

    Time frame: Postoperative 30 days

  3. Stroke

    Time frame: Postoperative 30 days

  4. Respiratory failure

    Time frame: Postoperative 30 days

  5. Renal dysfunction

    Time frame: Postoperative 30 days

  6. Renal failure

    Time frame: Postoperative 30 days

  7. Cardiogenic shock

    Time frame: Postoperative 30 days

  8. Gastrointestinal complication

    Time frame: Postoperative 30 days

Secondary outcomes

  1. Length of ICU stay

    Time frame: Postoperative 3 months

  2. Length of postoperative hospital stay

    Time frame: Postoperative 3 months

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Asan Medical Center

Registry information

Official study title

The Effect of Remote Ischemic Preconditioning on Mortality and Morbidity in Cardiac Surgery: a Randomized Controlled Trial

Acronym: RIPC

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2009
Registry last updated
Feb 24, 2011

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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