Study Results
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Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2008-11-30
2014-09-30
Brief Summary
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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
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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erythromycin group
Patients of erythromycin group: 25mg/kg erythromycin intravenously 12 hours before surgery and 12 hours after the end of surgery.
No interventions assigned to this group
control group
no administration of erythromycin
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* cerebrovascular disease with residual deficits
* stroke
* alcoholism
* psychiatric disease
18 Years
80 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
AHEPA University Hospital
OTHER
Responsible Party
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Evanthia Thomaidou
Consultant Anesthesiologist
Principal Investigators
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George Vretzakis, Prof.
Role: STUDY_DIRECTOR
University of Thessaly
Locations
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Ahepa University Hospital
Thessaloniki, Hotmail, Greece
Ahepa University Hospital
Thessaloniki, , Greece
Countries
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References
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Thomaidou E, Argiriadou H, Vretzakis G, Megari K, Taskos N, Chatzigeorgiou G, Anastasiadis K. Perioperative Use of Erythromycin Reduces Cognitive Decline After Coronary Artery Bypass Grafting Surgery: A Pilot Study. Clin Neuropharmacol. 2017 Sep/Oct;40(5):195-200. doi: 10.1097/WNF.0000000000000238.
Other Identifiers
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VRTE
Identifier Type: -
Identifier Source: org_study_id