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NCT00978419 · ClinicalTrials.gov registry record · Phase 2

Pilot Trial of Statin Use in Burn Patients

A Phase 2 study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00978419 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 40 participants.

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The verdict

NCT00978419, a Phase 2 study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Rosuvastatin

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2010-03
Est. Completion 2011-05
Phase Phase 2

What the Registry Record Tells You About NCT00978419

The ClinicalTrials.gov registry entry for NCT00978419 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00978419 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00978419 about?

NCT00978419 is a clinical study titled "Pilot Trial of Statin Use in Burn Patients". 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 ...

What is the current status of trial NCT00978419?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2010-03. Estimated completion is 2011-05.

What interventions are being tested in trial NCT00978419?

The interventions under investigation include: Placebo (DRUG), Rosuvastatin (DRUG).

Who is sponsoring clinical trial NCT00978419?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.