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

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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