Phase 4
Completed N=61
Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
Perioperative Inflammatory Response
Source: ClinicalTrials.gov NCT00656292 ↗
Enrolled (actual)
61
Serious AEs
7.6%
Results posted
May 2017
Primary outcomePrimary: Median Concentration of Aspartate Aminotransferase (AST) — 24.5; 24.5; 21.0; 20.0 U/L
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
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 | — |
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. Informational only — not medical advice.