Neuroprotection With Erythromycin in Cardiac Surgery
Recruitment status was Recruiting
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| First Received Date ICMJE | March 1, 2010 | ||||||||
| Last Updated Date | January 11, 2011 | ||||||||
| Start Date ICMJE | November 2008 | ||||||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
biochemical markers of brain ischemia and intraoperative cerebral oxymetry data [ Time Frame: September 2010 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01274754 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
better neurocognitive outcome in Erythromycin group [ Time Frame: November 2010 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Neuroprotection With Erythromycin in Cardiac Surgery | ||||||||
| Official Title ICMJE | Perioperative Administration of Erythromycin and Brain Protection | ||||||||
| 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. |
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| 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:
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,
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Blood samples will be taken from all patients for the detection of tau protein, IL-1 and IL-6,
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | patients scheduled for elective cardiac surgey coronary artery bypass grafting |
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| Condition ICMJE | Functional Disturbances Following Cardiac Surgery | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | June 2011 | ||||||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Greece | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01274754 | ||||||||
| Other Study ID Numbers ICMJE | VRTE | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Thomaidou Evanthia, AHEPA University Hospital | ||||||||
| Study Sponsor ICMJE | AHEPA University Hospital | ||||||||
| Collaborators ICMJE | University of Thessaly | ||||||||
| Investigators ICMJE |
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| Information Provided By | AHEPA University Hospital | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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