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Pilot Trial of Statin Use in Burn Patients

NCT00978419 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-06-01

Study results available
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Summary

This is a 90 day study, with patients receiving either oral Rosuvastatin or placebo for up to 28 days. The study will assess the affect of statins administered soon after burn injury on C-reactive protein (CRP) levels, patient mortality and the incidence of septic shock. The investigators also seek to describe the correlation between exposure to statins and development of delirium and de-novo long-term cognitive impairment.

Hypothesis:

1. Statin administration within 96 hours of burn is safe, will decrease CRP, and will decrease septic shock and mortality in burn patients.
2. The investigators hypothesize that burn patients will have a de-novo long term cognitive impairment at 3 months after burn.
3. The investigators hypothesize the use of statins in burn patients will reduce the development and the degree of cognitive impairment at 3 months post burn.

Conditions

  • Burns

Interventions

DRUG

Rosuvastatin

Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days

DRUG

Placebo

Placebo administered every day for up to 28 days

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-02-28
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00978419 on ClinicalTrials.gov