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Neuroprotection With Erythromycin in Cardiac Surgery

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 12, 2011
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
University of Thessaly
Information provided by (Responsible Party):
Evanthia Thomaidou, AHEPA University Hospital

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.

Functional Disturbances Following Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Administration of Erythromycin and Brain Protection

Resource links provided by NLM:

Further study details as provided by Evanthia Thomaidou, AHEPA University Hospital:

Primary Outcome Measures:
  • biochemical markers of brain ischemia and intraoperative cerebral oxymetry data [ Time Frame: September 2010 ]

Secondary Outcome Measures:
  • better neurocognitive outcome in Erythromycin group [ Time Frame: November 2010 ]

Biospecimen Retention:   Samples Without DNA

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

Enrollment: 40
Study Start Date: November 2008
Study Completion Date: September 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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

  Show Detailed Description


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients scheduled for elective cardiac surgey coronary artery bypass grafting

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274754

Ahepa University Hospital
Thessaloniki, Hotmail, Greece, 54636
Ahepa University Hospital
Thessaloniki, Greece, 54636
Sponsors and Collaborators
AHEPA University Hospital
University of Thessaly
Study Director: George Vretzakis, Prof. University of Thessaly
  More Information

Responsible Party: Evanthia Thomaidou, Consultant Anesthesiologist, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT01274754     History of Changes
Other Study ID Numbers: VRTE
First Submitted: March 1, 2010
First Posted: January 12, 2011
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Evanthia Thomaidou, AHEPA University Hospital:
neurocognitive assessment

Additional relevant MeSH terms:
Pathologic Processes
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action