Overview

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

Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Simvastatin
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