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

Not Applicable

• Conditions: Aortic Valve Stenois
• Interventions: Drug: placebo (0.9% NaCl (normal saline)); Drug: N(2)-L-Alanine L-Glutamine dipeptide

• Registration Number: NCT03341169
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-14
• Study Start: 2018-03-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10
• Primary Completion: 2019-09-28
• Study Completion: 2019-09-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo (0.9% NaCl (normal saline))	-
Glutamine	N(2)-L-Alanine L-Glutamine dipeptide	Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)

Primary Outcome Measures

Name	Time	Method
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)	48 hours after surgery
Troponin-T(Tn-T) level	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Free fatty acid	10 minutes after ICU(intensive care unit) entrance
IL-6	10 minutes after ICU(intensive care unit) entrance
CRP	24 hours after surgery
cardiovascular index	24 hours after surgery
occurrence of sternal infections	Within 30 days postoperatively
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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of