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Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury (RIPC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yunseok Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01903161
First received: July 1, 2013
Last updated: June 7, 2015
Last verified: June 2015
  Purpose
The purpose of this study is to evaluate delayed myocardial protective effect of RIPC in patients undergoing cardiac valve replacement surgery.

Condition Intervention
Myocardial Injury
Procedure: delayed remote ischemic preconditioning
Procedure: control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury in Patients Undergoing Cardiac Valve Replacement Surgery

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Troponin I change [ Time Frame: before induction of anesthesia, postoperative 1, 6, 12, 24, 48, 72 hours ]

Secondary Outcome Measures:
  • serum creatinine changes [ Time Frame: before induction of anesthesia, postoperative 1, 3, 5 days ]

Enrollment: 160
Study Start Date: May 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: delayed remote ischemic preconditioning
applying pneumatic cuff on upper extremity (5 minutes cycles of limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times)
Procedure: delayed remote ischemic preconditioning
In the delayed RIPC group, RIPC is performed 24-48 hr before surgery by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.
Placebo Comparator: control
All the procedures were the same in the control group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
Procedure: control
In the control group, all the procedures were the same with delayed RIPC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.

Detailed Description:

Ischemic preconditioning is one of the strategies that can reduce perioperative myocardial injury. It is a concept that briefly induced ischemia and reperfusion before the myocardial injury can reduce the myocardial injury. But it is difficult to apply ischemic preconditioning in operative field, because cross-clamping of aorta or coronary artery is difficult and invasive. Afterward concept of remote ischemic preconditioning(RIPC) has introduced that ischemia of remote organs like kidneys, skeletal muscles can reduce distant myocardial injury.

It is known that myocardial protective effect of ischemic preconditioning have biphasic pattern. Early protective effect wanes after a few hours, then recurs after 24-48 hours, and can persist for up to 3-4 days. It is called second window of preconditioning or delayed ischemic preconditioning. Delayed ischemic preconditioning is similar to early ischemic preconditioning in mechanism but it is different that it produces protein that can mediate myocardial protection effect.

Unlike ischemic preconditioning, it is little known about delayed effect of RIPC. RIPC can be done by applying compression cuff on upper or lower extremities and it is noninvasive and easy to deliver compared to ischemic preconditioning that is done by aorta or coronary artery clamping.

Delayed ischemic preconditioning is performed one day before the surgery, and it is safe and easy to apply RIPC in a clinical setting. And in this study investigators are going to evaluate cardioprotective effect of delayed RIPC. Myocardial injury can be predicted by elevation of cardiac enzyme. Investigators are going to perform RIPC one day before the valve replacement surgery and compare troponin I with control group to assess cardioprotective effect of delayed RIPC.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 - 80 years of adult patient undergoing cardiac valve surgery

Exclusion Criteria:

  • Patient who did not agree to the study
  • Emergency operation
  • Using inotropics, mechanical assisting device
  • Severe liver disease (>Child class II )
  • Severe renal disease (Renal replacement therapy)
  • left ventricular ejection fraction < 30%
  • Co-operation of major surgery (Carotid endarterectomy )
  • Oral hypoglycemic agent (Sulfonylurea, Glibenclamide)
  • peripheral vascular disease affecting upper extremity
  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: NCT01903161

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Deok Man Hong, M.D., Ph. D. Seoul National University Hospital
Study Director: Tae Kyong Kim, M.D. Seoul National University Hospital
  More Information

Responsible Party: Yunseok Jeon, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01903161     History of Changes
Other Study ID Numbers: delayed RIPC
Study First Received: July 1, 2013
Last Updated: June 7, 2015

Keywords provided by Seoul National University Hospital:
delayed remote ischemic preconditioning
troponin
valve replacement surgery

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on March 24, 2017