Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

Phase 4

Completed

• Conditions: Hypertrophy, Left Ventricular; Aortic Stenosis; Myocardial Ischemia; Cardiopulmonary Bypass

• Registration Number: NCT01144039
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2007-11
• Status Verified: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Last Update Submitted: 2010-06-15
• Last Update Posted: 2010-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
flow propagational velocity
Isovolumic relaxation time
E-velocity
A-velocity
E/A ratio

Secondary Outcome Measures

Name	Time	Method
ejection fraction
cardiac output
mitral ring motion

Trial Locations

Locations (1)

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