Status:
COMPLETED
Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
Lead Sponsor:
Mayo Clinic
Conditions:
Perioperative Inflammatory Response
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of the present study is to quantify the degree of modulation, if any, in the perioperative inflammatory response associated with statins use. Specifically, we hypothesize that: In a popul...
Detailed Description
Previous studies have reported activation of the body's immune system during the perioperative period.1 Typically, this "stress response" is limited and goes unnoticed by the patient and health care t...
Eligibility Criteria
Inclusion
- 1\. Patients scheduled for elective major spine surgery (multilevel (2-6 level) open thoracic or lumbar spine surgery with instrumentation)
Exclusion
- Pregnancy
- Lactating females
- Oral or parenteral corticosteroid use in the past 30 days
- Elevation of AST or ALT \> 3x normal
- Elevation of creatinine kinase \> 2x normal
- Previous adverse drug reaction to any medication in the statin class
- Current use of fibrates, niacin, itraconazole, ketoconazole, macrolide antibiotics, HIV protease inhibitors and/or nefazodone
- Active liver disease
- Current statin use
- Anti-inflammatory use of the following medications within the last 30 days:
- Sulfasalazine
- Mycophenolate
- Cyclosporine
- Cyclophosphamide
- Azathioprine
- Chlorambucil
- Minocycline
- Myochrysine
- Penicillamine
- Hydroxychloroquine
- Leflunomide
- Any medications listed in 3 or 10 above in the post-operative period
- Use of Activated protein C at any time during the patients hospitalization
- Use of anti-inflammatory medications listed below within the last 30 days:
- Leflunomide
- Sulfasalazine
- Mycophenolate
- Cyclosporine
- Cyclophosphamide
- Azathioprine
- Chlorambucil
- Minocycline
- Myochrysine
- Penicillamine
- Hydroxychloroquine
- Methotrexate
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00656292
Start Date
April 1 2008
End Date
March 1 2016
Last Update
May 19 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905