Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
Overview
Tab Title Description
Study type
InterventionalDescribes 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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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:
- non-statin (control) group
- 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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Brown, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available