Neuroprotection With Erythromycin in Cardiac Surgery

December 1, 2014 updated by: Evanthia Thomaidou, AHEPA University Hospital

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

Completed

Conditions

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:

  1. To determine the effect of high-dose perioperative erythromycin administration on neurological outcome in patients undergoing cardiac surgery
  2. 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,

  1. preoperatively
  2. 12 hours after surgery
  3. the 6th day after surgery

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54636
        • Ahepa University Hospital
    • Hotmail
      • Thessaloniki, Hotmail, Greece, 54636
        • Ahepa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients scheduled for elective cardiac surgey coronary artery bypass grafting

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

AHEPA University Hospital

Collaborators

University of Thessaly

Investigators

  • Study Director: George Vretzakis, Prof., University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

January 11, 2011

First Posted (ESTIMATE)

January 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

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.

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