Statins for the Early Treatment of Sepsis

Phase 2

Terminated

• Conditions: Sepsis
• Interventions: Drug: Identical-appearing placebo; Drug: Simvastatin

• Registration Number: NCT00528580
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-12
• Study Start: 2008-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2018-05-07
• Results First Submitted QC: 2018-05-07
• Results First Posted: 2018-06-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Identical-appearing placebo	Identical-appearing placebo PO (or via NG or G-tube)
1	Simvastatin	Simvastatin 80 mg once daily PO (or via NG or G-tube)

Primary Outcome Measures

Name	Time	Method
Time to Clinical Stability	24 hours	Normalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States