Aortic Valve Stenois
Conditions
Brief summary
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.
Interventions
: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)
DRUGplacebo (0.9% NaCl (normal saline))
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)
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A Randomized, Double-Blinded, Placebo-Controlled Trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with between 20 and 80 years scheduled for aortic valve replacement alone or combined surgery including aortic valve replacement due to severe aortic valve stenosis
Exclusion criteria
* Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less) * patients who are considering surgery for coronary artery disease or who have a stenosis\> 70% * hemodynamically unstable patients undergoing emergency surgery or patients with intra-aortic balloon pump insertion * patients unable to make their own decisions, illiterate, foreigners * epilepsy * severe metabolic acidosis * pulmonary edema * history of myocardial infarction * elevation of total bilirubin or AST / ALT * Patients higher than normal, weighing more than 80 kg * with evidence of infection * pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme) | 1 day before the operation |
| Troponin-T(Tn-T) level | 1 day before the operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRP | a day before surgery | — |
| cardiovascular index | 10 minutes after ICU(intensive care unit) entrance | — |
| IL-6 | a day before surgery | — |
| mortality | During hospitalization regardless of length of stay or within 30 days of surgery if discharged | — |
| occurrence of cardiovascular complications | up to 1 year | \*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 |
| occurrence of sternal infections | Within 30 days postoperatively | — |
| Free fatty acid | a day before surgery | — |
Countries
South Korea
Contacts
Primary ContactJong Wook Song, MD
Outcome results
None listed