Neuroprotection With Erythromycin in Cardiac Surgery
Condition: Functional Disturbances Following Cardiac Surgery
Study type: Observational

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:

        1. To determine the effect of high-dose perioperative erythromycin administration on
           neurological outcome in patients undergoing cardiac surgery

        2. 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,

        1. preoperatively

        2. 12 hours after surgery

        3. the 6th day after surgery
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients scheduled for elective cardiac surgey coronary artery bypass grafting
      
Biospecimen description: 
      Blood samples will be taken from all patients for the detection of tau protein, IL-1 and
      IL-6,

        1. preoperatively

        2. 12 hours after surgery

        3. the 6th day after surgery
    
Keywords: neuroprotection; erythromycin; neurocognitive assessment