- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01274754
Neuroprotection With Erythromycin in Cardiac Surgery
Perioperative Administration of Erythromycin and Brain Protection
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.
Study Overview
Status
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Thessaloniki, Greece, 54636
- Ahepa University Hospital
-
-
Hotmail
-
Thessaloniki, Hotmail, Greece, 54636
- Ahepa University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
erythromycin group
Patients of erythromycin group: 25mg/kg erythromycin intravenously 12 hours before surgery and 12 hours after the end of surgery.
|
control group
no administration of erythromycin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
biochemical markers of brain ischemia and intraoperative cerebral oxymetry data
Time Frame: September 2010
|
September 2010
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
better neurocognitive outcome in Erythromycin group
Time Frame: November 2010
|
November 2010
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: George Vretzakis, Prof., University of Thessaly
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VRTE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Functional Disturbances Following Cardiac Surgery
-
National Yang Ming UniversityCheng-Hsin General HospitalUnknownOther Functional Disturbances Following Cardiac Surgery
-
University Hospital, CaenCompletedOther Functional Disturbances Following Cardiac SurgeryFrance
-
Eckhard MauermannRecruitingCardiac Functional Disturbances During SurgerySwitzerland
-
Dr. Tarit SahaTerminatedChronic Pain | Other Functional Disturbances Following Cardiac SurgeryCanada
-
Unity Health TorontoCompletedOther Functional Disturbances Following Cardiac SurgeryCanada
-
Oslo Metropolitan UniversityOslo University HospitalCompletedPain | Pain, Postoperative | Other Functional Disturbances Following Cardiac SurgeryNorway
-
Medical University of GdanskWithdrawnMemory Disorders | Other Functional Disturbances Following Cardiac SurgeryPoland
-
Universidade Federal do Rio de JaneiroCompletedFunctional Disturbance Following Cardiac SurgeryBrazil
-
Tampere University HospitalTampere University of TechnologyCompletedPostoperative; Dysfunction Following Cardiac Surgery | Postoperative; Dysfunction Following Lung SurgeryFinland
-
Hull University Teaching Hospitals NHS TrustCompletedPostoperative; Dysfunction Following Cardiac SurgeryUnited Kingdom