Clinical trial · Interventional
Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
Perioperative HMG-CoA-Reductase-Inhibitors: A Pilot Study Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Perioperative Inflammatory Response | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Simvastatin
- description
- Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
- interventionNames
- Drug: Simvastatin
- type
- EXPERIMENTAL
- label
- Placebo
- description
- Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
* MethotrexateReferences
Publications (0)
Data not yet available