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Statins for Acutely Injured Lungs From Sepsis

NCT00979121 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 745

Last updated 2016-05-16

Study results available
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Summary

Objective: assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI).

Hypothesis: Rosuvastatin therapy will improve mortality in patients with sepsis-induced ALI.

Conditions

Interventions

DRUG

Rosuvastatin

Subjects received an initial 40mg loading dose followed by 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital.

DRUG

Placebo

Subjects received placebo by mouth or feeding tube daily for 28 days or until discharged from study hospital.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Jonathon Truwit, MD · University of Virginia, Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00979121 on ClinicalTrials.gov