Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
Condition: Perioperative Inflammatory Response
Intervention: Simvastatin; Placebo
Intervention description: 40 mg po/nasogastric tube (NG) every day for 6 days; 1 pill po/NG every day x 6 days
Intervention MeSH terms: Simvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Plasma concentrations of inflammatory markers; C-Reactive Protein (CRP); Interleukin-6 (IL-6); Tumor Necrosis Factor-Alpha (TNF); Aspartate Aminotransferase (AST); Alanine Aminotransferase (ALT); Creatine Kinase (CK)

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 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
    

Eligibility criteria:

        Inclusion Criteria:

        1. Patients scheduled for elective major spine surgery (multilevel (2-6 level) open
        thoracic or lumbar spine surgery with instrumentation)

        Exclusion Criteria:

          1. Pregnancy

          2. Lactating females

          3. Oral or parenteral corticosteroid use in the past 30 days

          4. Elevation of AST or ALT > 3x normal

          5. Elevation of creatinine kinase > 2x normal

          6. Previous adverse drug reaction to any medication in the statin class

          7. Current use of fibrates, niacin, itraconazole, ketoconazole, macrolide antibiotics,
             HIV protease inhibitors and/or nefazodone

          8. Active liver disease

          9. Current statin use

         10. Anti-inflammatory use of the following medications within the last 30 days:

               -  Sulfasalazine

               -  Mycophenolate

               -  Cyclosporine

               -  Cyclophosphamide

               -  Azathioprine

               -  Chlorambucil

               -  Minocycline

               -  Myochrysine

               -  Penicillamine

               -  Hydroxychloroquine

               -  Leflunomide

         11. Any medications listed in 3 or 10 above in the post-operative period

         12. Use of Activated protein C at any time during the patients hospitalization

         13. Use of anti-inflammatory medications listed below within the last 30 days:

               -  Leflunomide

               -  Sulfasalazine

               -  Mycophenolate

               -  Cyclosporine

               -  Cyclophosphamide

               -  Azathioprine

               -  Chlorambucil

               -  Minocycline

               -  Myochrysine

               -  Penicillamine

               -  Hydroxychloroquine

               -  Methotrexate