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

Aortic Valve Stenois Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03341169
• Other study ID #: 4-2017-0774
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: September 28, 2019

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: Jong Wook Song, MD
• Phone: 82-2-2227-3971
• Email: SJW72331[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: September 28, 2019
• Est. primary completion date: September 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenois
• Aortic Valve Stenosis

Intervention

Drug:
• 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))
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)

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)		1 day before the operation
Primary	degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)		10 minutes after ICU(intensive care unit) entrance,
Primary	degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)		24 hours after surgery
Primary	degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)		48 hours after surgery
Primary	Troponin-T(Tn-T) level		1 day before the operation
Primary	Troponin-T(Tn-T) level		24 hours after surgery
Secondary	IL-6		a day before surgery
Secondary	IL-6		10 minutes after ICU(intensive care unit) entrance
Secondary	Free fatty acid		a day before surgery
Secondary	Free fatty acid		10 minutes after ICU(intensive care unit) entrance
Secondary	CRP		a day before surgery
Secondary	CRP		24 hours after surgery
Secondary	cardiovascular index		10 minutes after ICU(intensive care unit) entrance
Secondary	cardiovascular index		12 hours after surgery
Secondary	cardiovascular index		24 hours after surgery
Secondary	occurrence of sternal infections		Within 30 days postoperatively
Secondary	mortality		During hospitalization regardless of length of stay or within 30 days of surgery if discharged
Secondary	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	up to 1 year