Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting
NCT ID: NCT00246740
Last Updated: 2017-12-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2005-10-31
2009-05-31
Brief Summary
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Detailed Description
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This study will be conducted in a blinded manner. The pharmacy will randomize patients and will have the randomization code. The code will only be broken in the case of an emergency and the event will be fully documented.
In addition to standard care, patients will receive oral administration of 20 mg of doxycycline or placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
Myocardial atrial biopsies will be taken at 2 time points during the CABG procedure: during cannulation of the right atrium and 10 minutes after cross-clamp release. Tissue will be analyzed for MMP-2 and -9 activity and TnI and MLC-1 levels.
A Swan-Ganz-Catheter will be placed in the pulmonary artery over 24 hours to measure hemodynamics (LVSWI).
A coronary sinus catheter will be placed under echocardiographic guidance prior to initiation of CPB (will be removed 20 minutes after cross-clamp release).
Patients will have an additional ECG on post-operative days 1 and 3.
Additional blood will be drawn to determine doxycycline plasma levels, MMP-2 and -9 activity, total gelatinolytic activity, and levels of troponin I and T products at the following time points: pre-induction, prior to initiation of CPB, 10 and 20 minutes following the release of the aortic cross clamp (arterial and venous) and 3, 6, 24 and 72 hours post aortic cross clamp removal (venous). Each of the above samples will require 6 mL of blood for a study total of 72 mL. At the time of each blood draw we will measure and record the hematocrit value.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo oral tablet
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet
In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
Periostat
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat
In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
Interventions
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Periostat
In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
Placebo Oral Tablet
In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18 through 80 years, inclusive
* Scheduled for primary CABG surgery with CPB
Exclusion Criteria
* Emergency CABG
* Previous sternotomy
* Planned simultaneous surgery (i.e. valve repair or carotid endarterectomy)
* Myocardial infarction within 48 hours
* Pre-operative atrial fibrillation
* Pre-operative ventricular pacing or left bundle branch block (LBBB)
* Known hypersensitivity to tetracycline class antibiotics
* Renal failure requiring dialysis
18 Years
80 Years
ALL
No
Sponsors
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University of Alberta
OTHER
Responsible Party
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Barry Finegan
Professor
Principal Investigators
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Barry A Finegan, FFARCS FRCPC
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology and Pain Medicine, University of Alberta Hospital
Locations
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University of Alberta Hospital
Edmonton, Alberta, Canada
Countries
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References
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Schulze CJ, Castro MM, Kandasamy AD, Cena J, Bryden C, Wang SH, Koshal A, Tsuyuki RT, Finegan BA, Schulz R. Doxycycline reduces cardiac matrix metalloproteinase-2 activity but does not ameliorate myocardial dysfunction during reperfusion in coronary artery bypass patients undergoing cardiopulmonary bypass. Crit Care Med. 2013 Nov;41(11):2512-20. doi: 10.1097/CCM.0b013e318292373c.
Related Links
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DOI of published results paper
Other Identifiers
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Protect Study Protocol
Identifier Type: -
Identifier Source: org_study_id