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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2019-09-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Valve Stenois

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Randomized, Double-Blinded, Placebo-Controlled Trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glutamine

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

Group Type EXPERIMENTAL

N(2)-L-Alanine L-Glutamine dipeptide

Intervention Type DRUG

: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

Group Type PLACEBO_COMPARATOR

placebo (0.9% NaCl (normal saline))

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No