Overview

This trial is active, not recruiting.

Condition sepsis
Treatments simvastatin, identical-appearing placebo
Phase phase 2
Sponsor University of Chicago
Start date February 2008
End date March 2012
Trial size 250 participants
Trial identifier NCT00528580, 15420A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Simvastatin 80 mg once daily PO (or via NG or G-tube)
simvastatin
80 mg once daily PO/NG x 4 days
(Placebo Comparator)
Identical-appearing placebo PO (or via NG or G-tube)
identical-appearing placebo
once daily x 4 days

Primary Outcomes

Measure
Time to clinical stability
time frame: 24 hours

Secondary Outcomes

Measure
Admission to the intensive care unit
time frame: 28 days
Use of mechanical ventilation (yes or no)
time frame: 28 days
Use of vasopressors for blood pressure support
time frame: 28 days
Length of hospital stay
time frame: 28 days
Hospital-free days to day 28
time frame: 28 days
ICU-free days to Day 28
time frame: 28 days
Antibiotic-free days to day 28
time frame: 28 days
Death or discharge to hospice
time frame: 28 days
Total ICU costs
time frame: 28 days
Total hospital costs
time frame: 28 days
Signs or symptoms of liver toxicity, myositis, elevations in LFTs or CPK, rhabdomyolysis.
time frame: 28 days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Statins for the Early Treatment of Sepsis
Principal investigator Jerry Krishnan, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by University of Chicago.