Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01274754 |
| Other study ID # |
VRTE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
March 1, 2010 |
| Last updated |
December 1, 2014 |
| Start date |
November 2008 |
| Est. completion date |
September 2014 |
Study information
| Verified date |
December 2014 |
| Source |
AHEPA University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Greece: Ethics Committee |
| Study type |
Observational
|
Clinical Trial 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.
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
