Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

NCT ID: NCT01144039

Last Updated: 2010-06-16

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-09-30

Brief Summary

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Purpose: The effect of intravenous glutamate infusion on myocardial diastolic function and overall hemodynamics were studied in patients undergoing elective aortic valve replacement with severe aortic stenosis and associated left ventricular hypertrophy .

Methods: 25 patients will be included in this double-blind randomized placebo-controlled study. Glutamate was administered intravenously immediately after aortic cross-clamp release. The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1 h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal echocardiography (TEE) is used to measure diastolic and systolic ventricular function before sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally routine hemodynamic parameters are measured intraoperatively.

Detailed Description

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Conditions

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Hypertrophy, Left Ventricular Aortic Stenosis Myocardial Ischemia Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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LG-group

Intervention Type DRUG

HG-group

Intervention Type DRUG

Placebo-group

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* severe aortic stenosis
* left ventricular hypertrophy of more than 10mm IVS thickness
* normal ejection fraction
* SR

Exclusion Criteria

* moderately or severely reduced systolic left ventricular function (ejection fraction \<30%)
* atrial fibrillation or flutter
* intolerance to glutamate.
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Locations

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Clin. Dept. of Cardiothoracic and Vascular Anaesthesia & Intensive Medicine, Medical University of Vienna, Vienna General Hospital

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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VI_echo_01_2006

Identifier Type: -

Identifier Source: org_study_id

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