Functional Disturbances Following Cardiac SurgeryNCT01274754
Neuroprotection With Erythromycin in Cardiac Surgery
An observational study of Functional Disturbances Following Cardiac Surgery, run by AHEPA University Hospital at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Disturbances Following Cardiac Surgery
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 2 sitesGreece
- Study dates
- Nov 2008to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for elective cardiac surgey coronary artery bypass grafting
Who may be able to join
- patients < 80 years old scheduled for elective cardiac surgery coronary artery bypass grafting, good cooperation with the clinical psychologist
Who cannot join
- patients > 80 years old
- cerebrovascular disease with residual deficits
- stroke
- alcoholism
- psychiatric disease
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Ahepa University Hospital
Thessaloniki, Hotmail, 54636
Ahepa University Hospital
Thessaloniki, 54636
About this study
Official title: 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.
Read the 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:
- To determine the effect of high-dose perioperative erythromycin administration on neurological outcome in patients undergoing cardiac surgery
- 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,
- preoperatively
- 12 hours after surgery
- the 6th day after surgery
- Keywords
- neuroprotection, erythromycin, neurocognitive assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
biochemical markers of brain ischemia and intraoperative cerebral oxymetry data
Measured: September 2010
Secondary outcomes (1)
better neurocognitive outcome in Erythromycin group
Measured: November 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startNov 2008
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Disturbances Following Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly
- Responsible party
- Principal investigator, Evanthia Thomaidou, AHEPA University Hospital
- Investigators
- George Vretzakis, Prof., Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274754
- Sponsor's protocol ID
- VRTE
- Status last verified
- Dec 2014
- First submitted
- 1 Mar 2010
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomaidou E, Argiriadou H, Vretzakis G, Megari K, Taskos N, Chatzigeorgiou G, Anastasiadis K. Perioperative Use of Erythromycin Reduces Cognitive Decline After Coronary Artery Bypass Grafting Surgery: A Pilot Study. Clin Neuropharmacol. 2017 Sep/Oct;40(5):195-200. doi: 10.1097/WNF.0000000000000238.
PubMed 28816833
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Administration of Erythromycin and Brain Protection
- ClinicalTrials.gov ID
- NCT01274754
- Acronym / sponsor ID
- VRTE
- Keywords
- neuroprotection, erythromycin, neurocognitive assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Collaborators
- University of Thessaly
- Study start
- Nov 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To determine the effect of high-dose perioperative erythromycin administration on neurological outcome in patients undergoing cardiac surgery
- 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,
- preoperatively
- 12 hours after surgery
- the 6th day after surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for elective cardiac surgey coronary artery bypass grafting
Key inclusion criteria (1 listed)
- patients < 80 years old scheduled for elective cardiac surgery coronary artery bypass grafting, good cooperation with the clinical psychologist
Key exclusion criteria (5 listed)
- patients > 80 years old
- cerebrovascular disease with residual deficits
- stroke
- alcoholism
- psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
biochemical markers of brain ischemia and intraoperative cerebral oxymetry data
Time frame: September 2010
1 secondary outcome
better neurocognitive outcome in Erythromycin group
Time frame: November 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 28816833Thomaidou E, Argiriadou H, Vretzakis G, Megari K, Taskos N, Chatzigeorgiou G, Anastasiadis K. Perioperative Use of Erythromycin Reduces Cognitive Decline After Coronary Artery Bypass Grafting Surgery: A Pilot Study. Clin Neuropharmacol. 2017 Sep/Oct;40(5):195-200. doi: 10.1097/WNF.0000000000000238.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Vretzakis, Prof. study director
University of Thessaly
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Disturbances Following Cardiac Surgery, run by AHEPA University Hospital at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical markers of brain ischemia and intraoperative cerebral oxymetry data (time frame: September 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01274754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.