Statins for the Early Treatment of Sepsis (SETS)
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ClinicalTrials.gov Identifier: NCT00528580 |
Recruitment Status :
Terminated
(Inadequate recruitment)
First Posted : September 12, 2007
Results First Posted : June 7, 2018
Last Update Posted : September 5, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sepsis | Drug: Simvastatin Drug: Identical-appearing placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Statins for the Early Treatment of Sepsis |
Actual Study Start Date : | February 2008 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Simvastatin 80 mg once daily PO (or via NG or G-tube)
|
Drug: Simvastatin
80 mg once daily PO/NG x 4 days |
Placebo Comparator: 2
Identical-appearing placebo PO (or via NG or G-tube)
|
Drug: Identical-appearing placebo
once daily x 4 days |
- Time to Clinical Stability [ Time Frame: 24 hours ]Normalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
- Clinically suspected infection as per the treating physician or confirmed infection
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528580
United States, Illinois | |
The University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Jerry Krishnan, MD | University of Chicago |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00528580 |
Other Study ID Numbers: |
15420A |
First Posted: | September 12, 2007 Key Record Dates |
Results First Posted: | June 7, 2018 |
Last Update Posted: | September 5, 2018 |
Last Verified: | August 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Sepsis Statin Infection Immunomodulatory |
Sepsis Toxemia Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Simvastatin |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |