Statins for the Early Treatment of Sepsis
| Status: | Terminated |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/7/2018 |
| Start Date: | February 2008 |
| End Date: | September 2011 |
We propose a Phase II, randomized, placebo-controlled clinical trial to test the hypothesis
that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and
clinical outcomes in adults hospitalized with sepsis. As our animal models suggest
pretreatment with statins are required for their beneficial effects, we propose a study
design intended to identify patients and initiate treatment early in their hospital stay.
This Phase II study is intended to assess the feasibility of conducting a large-scale
investigator-initiated translational research protocol that involves multiple clinical
services within the Department of Medicine.
that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and
clinical outcomes in adults hospitalized with sepsis. As our animal models suggest
pretreatment with statins are required for their beneficial effects, we propose a study
design intended to identify patients and initiate treatment early in their hospital stay.
This Phase II study is intended to assess the feasibility of conducting a large-scale
investigator-initiated translational research protocol that involves multiple clinical
services within the Department of Medicine.
Inclusion Criteria:
- Age > 18 years
- Initial presentation to the Emergency Department or University of Chicago MD
office/Dialysis Center for current hospital admission
- Sepsis (ACCP/SCCM criteria)
1. Clinically suspected infection as per the treating physician or confirmed
infection
2. 2 or more of the following: Temperature 38ºC (100.4ºF)or 36ºC (96.8ºF), Heart
rate (HR) > 90/min, Respiratory rate (RR) > 20/min or PaCO2 < 32 mmHg, White
blood cell count > 12,000/mm3 or < 4000/m3 or > 10%immature neutrophils
- Initiation of antibiotics by treating physician for sepsis
- Hospitalized from the Emergency Department or University of Chicago MD office/Dialysis
Center to an inpatient medical service (intensive care unit (ICU)or non-ICU service)
OR admission to the medical ICU (MICU) from a non-ICU inpatient medical floor.
- Assent of the primary treating physician at the time of enrollment.
- The meeting of SIRS criteria is due to an infection as per the treating physician.
Exclusion Criteria:
- Pregnancy
- ALT >3 times above the upper limit of normal
- Elevated creatine phosphokinase (CPK) (>3 times the upper limit of normal)
- Concurrent treatment with any of the following drugs: daptomycin, fenofibrate,
ketoconazole,triaconazole, amiodarone, clarithromycin, cyclosporine,
erythromycin,nefazodone, niacin, protease inhibitors, telithromycin,
verapamil,danazol, gemfibrozil
- History of allergy or intolerance to statins
- Greater than 16 hours after meeting inclusion criteria
- Use of 1 more doses of statins in the previous 4 weeks
- Clinical indication for treatment with statin during hospital admission (per treating
physician)
- Sufficiently poor prognosis prior to enrollment that treating physicians have elected
to employ comfort care or plan to discharge to hospice
- Transfer from surgical service to medical service
- Needing transfusion for either active bleeding or severe hemolysis.
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