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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Trade Name: Adenosine (Adenocor) Product Name: Adenocor Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Adenocor Current Sponsor code: PL 11723/0005 Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use CONDITION: Neuro psychological dysfunction post cardiac by‐pass surgery PRIMARY OUTCOME: Main Objective: To assess if adenosine has a neuro protective effect in patients undergoing cardiac by‐pass surgery Primary end point(s): Primary endpoint; 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.; ; Secondary endpoint; Will assess the changes in the haemodynamic status, inotropic requirement, mediastinal haemorrhage and blood product requirement of patients treated with adenosine.; Secondary Objective: Assess the changes in haemodynamic status ie inotropic requirements etc 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
Epistemonikos ID: 5cd7679dca168dac41b7fd49173fefd647a48f2f
First added on: Aug 21, 2024