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

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 06-002881
  • NCT ID:

    NCT00656292
  • Sponsor Protocol Number:

    06-002881

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • After approval from the Mayo Institutional Review Board, adult (age 18y-80y) patients scheduled for elective major spine surgery [multilevel (2-6 level) open thoracic or lumbar spine surgery with instrumentation] will be randomly assigned to one of the following two groups:
    1. non-statin (control) group
    2. perioperative statin group

Exclusion Criteria:

  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Brown, M.D.

Status Unknown

Lavonne Liedl R.R.T.

(507)255-1828

liedl.Lavonne@mayo.edu