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The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery (RIPC)

This study has been completed.
Sponsor:
Collaborator:
Asan Medical Center
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00997217
First received: October 15, 2009
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Myocardium; Injury
Cardiac Surgical Procedures
Procedure: remote ischemic preconditioning
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Remote Ischemic Preconditioning on Mortality and Morbidity in Cardiac Surgery: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • In-hospital death [ Time Frame: Postoperative 30 days ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: Postoperative 30 days ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: Postoperative 30 days ] [ Designated as safety issue: Yes ]
  • Respiratory failure [ Time Frame: Postoperative 30 days ] [ Designated as safety issue: Yes ]
  • Renal dysfunction [ Time Frame: Postoperative 30 days ] [ Designated as safety issue: Yes ]
  • Renal failure [ Time Frame: Postoperative 30 days ] [ Designated as safety issue: Yes ]
  • Cardiogenic shock [ Time Frame: Postoperative 30 days ] [ Designated as safety issue: Yes ]
  • Gastrointestinal complication [ Time Frame: Postoperative 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of ICU stay [ Time Frame: Postoperative 3 months ] [ Designated as safety issue: Yes ]
  • Length of postoperative hospital stay [ Time Frame: Postoperative 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1200
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: remote ischemic preconditioning
    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 Name: Blood pressure pneumatic cuff
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997217

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Asan Medical Center
Investigators
Study Director: YunSeok Jeon, professor Department of Anesthesiology and Pain Medicine, SNUH
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeon, YunSeok, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00997217     History of Changes
Other Study ID Numbers: RIPCmulticenter
Study First Received: October 15, 2009
Last Updated: February 22, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
RIPC
cardiac surgery
ischemic preconditioning
cardiac surgical procedures

ClinicalTrials.gov processed this record on November 19, 2014