Neuroprotection With Erythromycin in Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
University of Thessaly
Information provided by (Responsible Party):
Evanthia Thomaidou, AHEPA University Hospital
ClinicalTrials.gov Identifier:
NCT01274754
First received: March 1, 2010
Last updated: December 1, 2014
Last verified: December 2014
  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.

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
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 AHEPA University Hospital:

Primary Outcome Measures:
  • biochemical markers of brain ischemia and intraoperative cerebral oxymetry data [ Time Frame: September 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • better neurocognitive outcome in Erythromycin group [ Time Frame: November 2010 ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: March 1, 2010
Last Updated: December 1, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on July 28, 2016