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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
80 mg once daily PO/NG x 4 days
once daily x 4 days
The University of Chicago
Chicago, Illinois, United States
Time to Clinical Stability
Normalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.
Time frame: 24 hours
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