Conditions: Sepsis
Keywords: Sepsis Statin Infection Immunomodulatory
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 68
Healthy volunteers: no

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:

Arms:
arm 1: Simvastatin 80 mg once daily PO (or via NG or G-tube) arm 2: Identical-appearing placebo PO (or via NG or G-tube)

Interventions: intervention 1: Simvastatin intervention 2: Identical-appearing placebo
Intervention descriptions: intervention 1: 80 mg once daily PO/NG x 4 days intervention 2: once daily x 4 days

Protocol document: