Neuroprotection With Erythromycin in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Neurological complications occur in open heart surgery with a frequency of 40% and they range from major neurological deficits (due to a stroke) to neurocognitive and behavioral disorders. This study aims to determine if erythromycin, a worldwide known antibiotic, protects the brain from damage when given in high doses before and during open heart surgery. The investigators consume that high dose of erythromycin will protect the brain with a pharmacological preconditioning against the global ischemia during the perioperative period of heart surgery.

Detailed Description
-----------------
First Version: Study Protocol Authors: Thomaidou E., Vretzakis G., Argiriadou E., Stamatiou G., et al. Perioperative administration of erythromycin and brain protection Study Setting: On-pump, planned cardiac surgery. Randomized, double blinded clinical trial of two parallel groups. Group A: control group. Group B: erythromycin group (dose 25mg/kg intravenously). Purpose: Neurological complications occur in open heart surgery with a frequency of 40% and they range from major neurological deficits (due to a stroke) to neurocognitive and behavioral disorders. This study aims to determine if erythromycin, a worldwide known antibiotic, protects the brain from damage when given in high doses before and during open heart surgery. Hypothesis: The investigators consume that high dose of erythromycin will protect the brain with a pharmacological preconditioning against the global ischemia during the perioperative period of heart surgery. The aims of this study are: To determine the effect of high-dose perioperative erythromycin administration on neurological outcome in patients undergoing cardiac surgery To determine the relationship of neurological monitoring, specifically NIRS, to neurological outcomes and to determine if erythromycin affects this relationship. Preoperative Period Patient Exclusion Criteria: patients > 80 years old, cerebrovascular disease with residual deficits, stroke, alcoholism, psychiatric disease. Preoperative patient neurocognitive status assessment from the same clinical psychologist in all patients: at least one day before surgery, perform neurocognitive tests. Patients of group A: 25mg/kg erythromycin intravenously 12 hours before surgery. Intraoperative Period Cerebral monitoring: continuous measurement and registration of cerebral oximetry data (NIRS - INVOS), record of frequency and duration of desaturation episodes (a fall >20% compared to baseline values) and record of interventions to correct desaturation. Anaesthesia depth monitoring: continuous measurement of bispectral index (BIS). Registration of: duration of CPB and cross clamp time, mean arterial pressure, heart rate, temperature and ETCO2. Anesthesia Procedures: anesthesia induction with fentanyl 10-15μg/kg, propofol 2gm/kg and rocuronium 0,6mg/kg. Anesthesia maintenance with propofol. Postoperative Period - ICU Postoperative patient neurocognitive status assessment from the same clinical psychologist in all patients: On discharge, and 3 months later perform neurocognitive tests. Patients of group A: will receive high dose of erythromycin 12 hours after the end of surgery. Registration of: Post operative blood loss, duration of ICU stay, mechanical ventilation duration, duration of hospital stay, inotropic support, postoperative myocardial infarction, re-operation, dialysis, neurocognitive decline, other complications. BIOCHEMICAL INDEX Blood samples will be taken from all patients for the detection of tau protein, IL-1 and IL-6, preoperatively 12 hours after surgery the 6th day after surgery

Official Title
-----------------
Perioperative Administration of Erythromycin and Brain Protection

Conditions
-----------------
Functional Disturbances Following Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients < 80 years old scheduled for elective cardiac surgery coronary artery bypass grafting, good cooperation with the clinical psychologist Exclusion Criteria: patients > 80 years old cerebrovascular disease with residual deficits stroke alcoholism psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| erythromycin group<br>Patients of erythromycin group: 25mg/kg erythromycin intravenously 12 hours before surgery and 12 hours after the end of surgery. | |
| control group<br>no administration of erythromycin | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical markers of brain ischemia and intraoperative cerebral oxymetry data |  | September 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| better neurocognitive outcome in Erythromycin group |  | November 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuroprotection, erythromycin, neurocognitive assessment