MedTrace Logo

Statins for the Early Treatment of Sepsis

NCT00528580 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2018-09-05

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Simvastatin

80 mg once daily PO/NG x 4 days

DRUG

Identical-appearing placebo

once daily x 4 days

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Jerry Krishnan, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-09-30
Completion
2011-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00528580 on ClinicalTrials.gov