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Effect of Intravenous Adenosine on neuro-psychological dysfunction post coronary artery bypass surgery

Phase 1
Conditions
euro psychological dysfunction post cardiac by-pass surgery
Registration Number
EUCTR2005-002794-79-GB
Lead Sponsor
Swansea NHS Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

Aged 18 or older having first time isolated CABG
Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Steroid usage, pregnancy, Atrial venticular black or sinus node dysfunction - Bronchoconstrictive disease/hypersensitivity to adenosine

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To assess if adenosine has a neuro protective effect in patients undergoing cardiac by-pass surgery;Secondary Objective: Assess the changes in haemodynamic status ie inotropic requirements etc;<br> Primary end point(s): Primary endpoint<br> To assess whether adenosine has a neuro-protective effect which is clinically translated into improvement of neuro-psychometric dysfunction when tested by the CANTAB” neuro-psychometric tests.<br><br> Secondary endpoint<br> Will assess the changes in the haemodynamic status, inotropic requirement, mediastinal haemorrhage and blood product requirement of patients treated with adenosine.<br>
Secondary Outcome Measures
NameTimeMethod
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