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

Primary Purpose

Aortic Valve Stenois

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
N(2)-L-Alanine L-Glutamine dipeptide
placebo (0.9% NaCl (normal saline))
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aortic Valve Stenois

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glutamine

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Troponin-T(Tn-T) level
Troponin-T(Tn-T) level

Secondary Outcome Measures

IL-6
IL-6
Free fatty acid
Free fatty acid
CRP
CRP
cardiovascular index
cardiovascular index
cardiovascular index
occurrence of sternal infections
mortality
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

Full Information

First Posted
October 23, 2017
Last Updated
January 9, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03341169
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
September 28, 2019 (Anticipated)
Study Completion Date
September 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenois

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized, Double-Blinded, Placebo-Controlled Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glutamine
Arm Type
Experimental
Arm Description
Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
N(2)-L-Alanine L-Glutamine dipeptide
Intervention Description
: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)
Intervention Type
Drug
Intervention Name(s)
placebo (0.9% NaCl (normal saline))
Intervention Description
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)
Primary Outcome Measure Information:
Title
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Time Frame
1 day before the operation
Title
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Time Frame
10 minutes after ICU(intensive care unit) entrance,
Title
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Time Frame
24 hours after surgery
Title
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Time Frame
48 hours after surgery
Title
Troponin-T(Tn-T) level
Time Frame
1 day before the operation
Title
Troponin-T(Tn-T) level
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
IL-6
Time Frame
a day before surgery
Title
IL-6
Time Frame
10 minutes after ICU(intensive care unit) entrance
Title
Free fatty acid
Time Frame
a day before surgery
Title
Free fatty acid
Time Frame
10 minutes after ICU(intensive care unit) entrance
Title
CRP
Time Frame
a day before surgery
Title
CRP
Time Frame
24 hours after surgery
Title
cardiovascular index
Time Frame
10 minutes after ICU(intensive care unit) entrance
Title
cardiovascular index
Time Frame
12 hours after surgery
Title
cardiovascular index
Time Frame
24 hours after surgery
Title
occurrence of sternal infections
Time Frame
Within 30 days postoperatively
Title
mortality
Time Frame
During hospitalization regardless of length of stay or within 30 days of surgery if discharged
Title
occurrence of cardiovascular complications
Description
*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
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Wook Song, MD
Phone
82-2-2227-3971
Email
SJW72331@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Wook Song, MD
Phone
82-2-2227-3971
Email
SJW72331@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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

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