Statins for the Early Treatment of Sepsis (SETS)

The University of Chicago

Status and phase

Terminated

Phase 2

Conditions

Sepsis

Treatments

Drug: Simvastatin

Drug: Identical-appearing placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00528580

15420A

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.