Brief Title
Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis
Official Title
Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis
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.
Study Type
Interventional
Primary Outcome
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Secondary Outcome
IL-6
Condition
Aortic Valve Stenois
Intervention
N(2)-L-Alanine L-Glutamine dipeptide
Study Arms / Comparison Groups
Glutamine
Description: Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
108
Start Date
March 20, 2018
Completion Date
September 28, 2019
Primary Completion Date
September 28, 2019
Eligibility Criteria
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
Gender
All
Ages
20 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
, 82-2-2227-3971, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03341169
Organization ID
4-2017-0774
Responsible Party
Sponsor
Study Sponsor
Yonsei University
Study Sponsor
, ,
Verification Date
January 2019