Neuroprotection With Erythromycin in Cardiac Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by AHEPA University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
AHEPA University Hospital
Collaborator:
University of Thessaly
Information provided by:
AHEPA University Hospital
ClinicalTrials.gov Identifier:
NCT01274754
First received: March 1, 2010
Last updated: January 11, 2011
Last verified: June 2009
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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:
MedlinePlus related topics:
Heart Surgery
Drug Information available for:
Erythromycin
Erythromycin stearate
Erythromycin ethylsuccinate
Erythromycin phosphate
U.S. FDA Resources
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,
- preoperatively
- 12 hours after surgery
- the 6th day after surgery
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | March 2011 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274754
Contacts
| Contact: George Vretzakis, Prof. | 00306946215721 | gvretzakis@yahoo.com |
| Contact: Georgia Stamatiou, Prof. | 00306978993102 | gstamat@yahoo.com |
Locations
| Greece | |
| Ahepa University Hospital | Recruiting |
| Thessaloniki, Hotmail, Greece, 54636 | |
| Contact: Evanthia Thomaidou, Dr 00302310993593 evathom1975@yahoo.gr | |
| Contact: Elena Argiriadou, Dr 00302310993868 argiriadou@hotmail.com | |
| Ahepa University Hospital | Recruiting |
| Thessaloniki, Greece, 54636 | |
| Contact: Evanthia V Thomaidou, Dr 00302310993599 evathom1975@yahoo.gr | |
| Contact: Elena G Argiriadou, Dr 00302310993868 argiriadou@hotmail.com | |
Sponsors and Collaborators
AHEPA University Hospital
University of Thessaly
Investigators
| Study Director: | George Vretzakis, Prof. | University of Thessaly |
More Information
No publications provided
| Responsible Party: | Thomaidou Evanthia, AHEPA University Hospital |
| ClinicalTrials.gov Identifier: | NCT01274754 History of Changes |
| Other Study ID Numbers: | VRTE |
| Study First Received: | March 1, 2010 |
| Last Updated: | January 11, 2011 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by AHEPA University Hospital:
|
neuroprotection erythromycin neurocognitive assessment |
Additional relevant MeSH terms:
|
Erythromycin stearate Erythromycin Erythromycin Estolate Erythromycin Ethylsuccinate Gastrointestinal Agents Therapeutic Uses |
Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013