Statins for the Early Treatment of Sepsis (SETS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Chicago.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00528580
First received: September 11, 2007
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Sepsis
Drug: Simvastatin
Drug: Identical-appearing placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Statins for the Early Treatment of Sepsis

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Time to clinical stability [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Admission to the intensive care unit [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Use of mechanical ventilation (yes or no) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Use of vasopressors for blood pressure support [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Length of hospital stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Hospital-free days to day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • ICU-free days to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Antibiotic-free days to day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Death or discharge to hospice [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Total ICU costs [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Total hospital costs [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Signs or symptoms of liver toxicity, myositis, elevations in LFTs or CPK, rhabdomyolysis. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: February 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00528580     History of Changes
Other Study ID Numbers: 15420A
Study First Received: September 11, 2007
Last Updated: February 23, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014