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

September 11, 2007
February 23, 2012
February 2008
March 2012   (final data collection date for primary outcome measure)
Time to clinical stability [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Time to clinical stability
Complete list of historical versions of study NCT00528580 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Admission to the intensive care unit
  • Use of mechanical ventilation (yes or no)
  • Use of vasopressors for blood pressure support
  • Length of hospital stay
  • Hospital-free days to day 28
  • ICU-free days to Day 28
  • Antibiotic-free days to day 28
  • Death or discharge to hospice
  • Total ICU costs
  • Total hospital costs
  • Signs or symptoms of liver toxicity, myositis, elevations in LFTs or CPK, rhabdomyolysis.
Not Provided
Not Provided
 
Statins for the Early Treatment of Sepsis
Statins for the Early Treatment of Sepsis

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sepsis
  • Drug: Simvastatin
    80 mg once daily PO/NG x 4 days
  • Drug: Identical-appearing placebo
    once daily x 4 days
  • Experimental: 1
    Simvastatin 80 mg once daily PO (or via NG or G-tube)
    Intervention: Drug: Simvastatin
  • Placebo Comparator: 2
    Identical-appearing placebo PO (or via NG or G-tube)
    Intervention: Drug: Identical-appearing placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
December 2013
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00528580
15420A
Yes
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Jerry Krishnan, MD University of Chicago
University of Chicago
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP