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

October 15, 2009
February 22, 2011
October 2009
September 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00997217 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery
The Effect of Remote Ischemic Preconditioning on Mortality and Morbidity in Cardiac Surgery: a Randomized Controlled Trial

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Myocardium; Injury
  • Cardiac Surgical Procedures
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
Not Provided
Hong DM, Lee EH, Kim HJ, Min JJ, Chin JH, Choi DK, Bahk JH, Sim JY, Choi IC, Jeon Y. Does remote ischaemic preconditioning with postconditioning improve clinical outcomes of patients undergoing cardiac surgery? Remote Ischaemic Preconditioning with Postconditioning Outcome Trial. Eur Heart J. 2014 Jan;35(3):176-83. doi: 10.1093/eurheartj/eht346. Epub 2013 Sep 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
November 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00997217
RIPCmulticenter
Yes
Jeon, YunSeok, Seoul National University Hospital
Seoul National University Hospital
Asan Medical Center
Study Director: YunSeok Jeon, professor Department of Anesthesiology and Pain Medicine, SNUH
Seoul National University Hospital
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP