Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis

Yonsei University108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

108

Conditions

Aortic Valve Stenois

Interventions

N(2)-L-Alanine L-Glutamine dipeptide

: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)

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)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)

Time frame: 1 day before the operation

degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)

Time frame: 10 minutes after ICU(intensive care unit) entrance,

degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)

Time frame: 24 hours after surgery

degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)

Time frame: 48 hours after surgery

Troponin-T(Tn-T) level

Time frame: 1 day before the operation

Troponin-T(Tn-T) level

Time frame: 24 hours after surgery

Secondary Outcomes

IL-6

Time frame: a day before surgery

IL-6

Time frame: 10 minutes after ICU(intensive care unit) entrance

Free fatty acid

Time frame: a day before surgery

Free fatty acid

Time frame: 10 minutes after ICU(intensive care unit) entrance

CRP

Time frame: a day before surgery

CRP

Time frame: 24 hours after surgery

cardiovascular index

Time frame: 10 minutes after ICU(intensive care unit) entrance

cardiovascular index

Time frame: 12 hours after surgery

cardiovascular index

Time frame: 24 hours after surgery

occurrence of sternal infections

Time frame: Within 30 days postoperatively

mortality

Time frame: 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

Time frame: up to 1 year

Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts