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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00656292 |
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
Condition | Intervention | Phase |
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Perioperative Inflammatory Response |
Drug: simvastatin Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Perioperative HMG-CoA-Reductase-Inhibitors: A Pilot Study Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery |
Estimated Enrollment: | 70 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Study groups will receive either statin therapy (simvastatin 40 mg) or placebo two days before surgery -- allowing three doses of simvastatin/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 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
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Drug: placebo |
2: Experimental
Study groups will receive either statin therapy (simvastatin 40 mg) or placebo two days before surgery -- allowing three doses of simvastatin/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 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
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Drug: simvastatin
40 mg po/NG every day for 6 days
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Previous studies have reported activation of the body's immune system during the perioperative period.1 Typically, this "stress response" is limited and goes unnoticed by the patient and health care team. However, physiologic insults that occur during major surgery may elicit a more pronounced response known as the systemic inflammatory response syndrome (SIRS). Such a response is of great clinical consequence, as it is known to significantly worsen perioperative morbidity and mortality.1 HMG Co-A Reductase Inhibitors (hereafter identified by the common name, "the statins") are potent inhibitors of cholesterol synthesis, and their role in the treatment of atherosclerosis and prevention of coronary artery disease is well documented.2-5 Interestingly, data from animal studies have shown that statins have unique anti-inflammatory properties that are independent of their lipid lowering effects.6 Recently, statin therapy has been associated with a reduced incidence of perioperative cardiovascular and neurologic complications in major vascular and thoracic surgery patients as well as improved outcomes in patients experiencing acute coronary syndrome (ACS).7-13 In all ACS patient populations studied, improvement in outcome has been attributed to coronary plaque stabilization, presumably a result of statins mitigating the local inflammatory response at the level of the coronary plaque.
The purpose of this study is to quantify the magnitude of perioperative inflammation during major orthopedic spine surgery and determine whether statins alter this systemic physiologic response.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Exclusion Criteria:
Exclusion criteria will include:
Anti-inflammatory use of the following medications within the last 30 days:
Use of anti-inflammatory medications listed below within the last 30 days:
Contact: Lavonne Liedl | 507-284-2511 | liedl.lavonne@mayo.edu |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Michael J. Brown, M.D. | Mayo Clinic Department of Anesthesiology |
Principal Investigator: | Daryl Kor, M.D. | Mayo Clinic Department of Anesthesiolgy |
Responsible Party: | Mayo Clinic ( Michael J. Brown M.D. ) |
Study ID Numbers: | 06-002881 |
Study First Received: | April 4, 2008 |
Last Updated: | April 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00656292 |
Health Authority: | United States: Institutional Review Board |
Plasma concentrations of inflammatory markers (CRP, IL-6, TNF-a), AST, ALT, and CK |
Simvastatin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |