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

Yonsei University

Status: Unknown

Conditions: Aortic Valve Stenois

Treatments: Drug: N(2)-L-Alanine L-Glutamine dipeptide; Drug: placebo (0.9% NaCl (normal saline))

Study type: Interventional

Funder types: Other

Identifiers

NCT03341169

4-2017-0774

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups, including a placebo group

Glutamine

Experimental group

Description:

Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)

Treatment:

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

Placebo

Placebo Comparator group

Treatment:

Drug: placebo (0.9% NaCl (normal saline))