Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery

Completed · Phase 4 · Has a placebo group

Conditions studied: Perioperative Inflammatory Response

In brief

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 population of patients undergoing elective orthopedic spine surgery, administration of a specific statin (Simvastatin, Zocor®, Merck Pharmaceuticals), will be associated with a decrease in perioperative inflammatory markers when compared to patients not taking statins

Key facts

Study ID

NCT00656292

Run by

Mayo Clinic

People needed

61

Starts

2008-04-01

Expected to finish

2016-03-01

Last updated by the study team

2017-05-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients scheduled for elective major spine surgery (multilevel (2-6 level) open thoracic or lumbar spine surgery with instrumentation)

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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