Clinical trial NCT01903161: Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury
Official title: Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury in Patients Undergoing Cardiac Valve Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Injury
Keywords: delayed remote ischemic preconditioning
troponin
valve replacement surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate delayed myocardial protective effect of RIPC in patients undergoing cardiac valve replacement surgery.

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 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

Primary outcomes:
measure: Troponin I change
timeFrame: before induction of anesthesia, postoperative 1, 6, 12, 24, 48, 72 hours
Secondary outcomes:
measure: serum creatinine changes
timeFrame: before induction of anesthesia, postoperative 1, 3, 5 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Deok Man Hong, M.D., Ph. D.
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Tae Kyong Kim, M.D.
role: STUDY_DIRECTOR
References: