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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
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief 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.

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

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

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




Primary Outcome Measures :
  1. 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
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.

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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


Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jerry Krishnan, MD University of Chicago

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00528580     History of Changes
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

Keywords provided by University of Chicago:
Sepsis
Statin
Infection
Immunomodulatory

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Simvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors