Statins for the Early Treatment of Sepsis

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Simvastatin

Criteria

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.