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The purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the degree of myocardial damage(with CK-MB and Troponin T) and myocardial protection (through hsp 70 expression in atrial tissue), cardiovascular index, inflammatory reaction, and clinical manifestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamine | Experimental | Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N(2)-L-Alanine L-Glutamine dipeptide | Drug | :Intravenous infusion of N (2) -L-alanyl-L-glutamine(mixed with normal saline, ratio 1:1) at the dose of 0.25g/kg(body weight) for 8 hours before induction of anesthesia(rate=2.5*weight/8 ml/h) and administration another 0.25g/kg(body weight) of N (2) -L-alanyl-L-glutamine(mixed with 8.5% amino acid solution, ratio 1:5) into the central vein for 10 hours after induction of anesthesia(rate=0.75*weight ml/h) |
| Measure | Description | Time Frame |
|---|---|---|
| degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme) | 1 day before the operation | |
| degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme) | 10 minutes after ICU(intensive care unit) entrance, | |
| degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme) | 24 hours after surgery | |
| degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme) | 48 hours after surgery | |
| Troponin-T(Tn-T) level | 1 day before the operation | |
| Troponin-T(Tn-T) level | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 | a day before surgery | |
| IL-6 | 10 minutes after ICU(intensive care unit) entrance | |
| Free fatty acid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Wook Song, MD | Contact | 82-2-2227-3971 | SJW72331@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine | Recruiting | Seoul | 03722 | South Korea |
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A Randomized, Double-Blinded, Placebo-Controlled Trial
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|
| placebo (0.9% NaCl (normal saline)) | Drug | Intravenous infusion of 0.9% NaCl for 8 hours before induction of anesthesia(rate=2.5*weight/8 ml/h) and administration 0.9% NaCl into the central vein for 10 hours after induction of anesthesia(rate=0.75*weight ml/h) |
|
| a day before surgery |
| Free fatty acid | 10 minutes after ICU(intensive care unit) entrance |
| CRP | a day before surgery |
| CRP | 24 hours after surgery |
| cardiovascular index | 10 minutes after ICU(intensive care unit) entrance |
| cardiovascular index | 12 hours after surgery |
| cardiovascular index | 24 hours after surgery |
| occurrence of sternal infections | Within 30 days postoperatively |
| mortality | During hospitalization regardless of length of stay or within 30 days of surgery if discharged |
| occurrence of cardiovascular complications | *cardiovascular (myocardial infarction, heart failure, arrhythmia), cerebral infarction, renal failure: During the hospitalization for surgery, which includes the entire postoperative period up to discharge, even if over 30 days | up to 1 year |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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