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Neuroprotection With Erythromycin in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01274754
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease
Functional Disturbances Following Cardiac Surgery

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Administration of Erythromycin and Brain Protection
Study Start Date : November 2008
Primary Completion Date : July 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

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


Locations
Greece
Ahepa University Hospital
Thessaloniki, Hotmail, Greece, 54636
Ahepa University Hospital
Thessaloniki, Greece, 54636
Sponsors and Collaborators
AHEPA University Hospital
University of Thessaly
Investigators
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 Posted: January 12, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

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

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