Phase 4
N=61
Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
Perioperative Inflammatory Response
Bottom Line
View on ClinicalTrials.gov: NCT00656292 ↗Enrolled (actual)
61
Serious AEs
7.6%
Results posted
May 2017
Primary outcome: Primary: Median Concentration of Aspartate Aminotransferase (AST) — 24.5; 24.5; 21.0; 20.0 U/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Simvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Concentration of Aspartate Aminotransferase (AST) |
24.5; 24.5; 21.0; 20.0; 29.0; 25.0 | — |
| SECONDARY Median Concentration of Alanine Aminotransferase (ALT) |
23; 22.0; 16.5; 16.0; 18.0; 16.5 | — |
| SECONDARY Median Concentration of C-Reactive Protein (CRP) |
3.0; 3.0; 3.0; 3.0; 3.0; 4.1 | — |
| SECONDARY Median Concentration of Creatine Kinase (CK) |
89.5; 111.0; 71.0; 103.0; 527.0; 257.0 | — |
| SECONDARY Median Concentration of Interleukin-6 (IL-6) |
1.5; 2.4; 1.2; 1.8; 50.0; 56.7 | — |
| SECONDARY Median Concentration of Tumor Necrosis Factor-Alpha (TNF) |
1.0; 0.85; 0.95; 0.96; 0.94; 0.86 | — |
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
- Patients scheduled for elective major spine surgery (multilevel (2-6 level) open thoracic or lumbar spine surgery with instrumentation)
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
Data sourced from ClinicalTrials.gov (NCT00656292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.