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Pilot Trial of Statin Use in Burn Patients (BURNSTAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978419
First Posted: September 16, 2009
Last Update Posted: July 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
  Purpose

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.

Condition Intervention Phase
Burns Drug: Rosuvastatin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Placebo Controlled, Pilot Trial of Statin Use in Burn Patients

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Primary endpoint: Reduction in CRP level over time, compared to placebo measured at baseline and days 3, 7, 14. The mean CRP levels at specified days will be the endpoints. [ Time Frame: Days 1, 3, 7, 14 ]

Secondary Outcome Measures:
  • mortality compared to placebo [ Time Frame: 90 days ]
  • mortality compared to placebo, adjusted for cardiovascular co-morbidities [ Time Frame: 90 days ]
  • Reduction in the incidence of septic shock (see definition) compared to placebo [ Time Frame: 28 days ]
  • Reduction in the incidence of septic shock (see definition) compared to placebo, adjusted for cardiovascular co-morbidities [ Time Frame: 28 days ]
  • A reduction in CK levels over time, compared to placebo measured at baseline and days 3, 7, 14, 21, 28 [ Time Frame: 28 days ]
  • A reduction in ALT levels over time, compared to placebo, measured at baseline, days 1, 7, 14, 21, 28 [ Time Frame: 28 days ]
  • Determine the safety of Rosuvastatin compared to placebo in burn patients by comparing the frequency, type and severity of adverse events [ Time Frame: 28 days ]
  • Determine which are appropriate attainable endpoints for future trials and the number of participants required to reach significance in analysis of a variety of variables [ Time Frame: 28 days ]
  • Determine the prevalence of delirium in the two subgroup of patients [ Time Frame: 28 days ]
  • Determine the prevalence of de-novo long-term neurocognitive impairment in burn patients and by study group. [ Time Frame: 90 days ]
  • Determine the prevalence of functional impairment in burn patients and by study group [ Time Frame: 90 days ]

Enrollment: 40
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rosuvastatin
Rosuvastatin
Drug: Rosuvastatin
Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo administered every day for up to 28 days

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Thermal burn occurring within the 96 hours prior to dosing

Exclusion Criteria:

  • Inability to obtain informed consent (or assent from surrogate)
  • Less than 18 years of age
  • Patient or surrogate not committed and/or not likely to remain committed to full support, as, for example, would be the case for a patient with end-stage cancer or other end-stage terminal conditions. Commitment to full support need not include cardiopulmonary resuscitation provided the team is committed to other forms of full support
  • Unable to receive or absorb enteral study drug
  • Statin specific exclusions
  • Receiving a statin medication within 48 hours of dosing (to exclude controls from exposure to statins)
  • Allergy or intolerance to statins
  • ALT or AST > 5 times upper limit of normal
  • Untreated hypothyroidism by history (package insert)
  • Pregnancy or breastfeeding
  • Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or oral contraceptives within 24 hours prior to admission (package insert)
  • Advanced cirrhosis, defined as a history of chronic liver disease and a Child-Pugh Class score >10 (Appendix A)
  • Moribund patient not expected to survive 24 hours
  • Patients admitted to the Burn Service for non-thermal burn conditions, including chemical burn, TENS, electrical injury or wound care
  • Patient expected to be discharged within 24 hours
  • Patients of Asian descent (due to pharmacokinetics issues with Rosuvastatin in this population)
  • Patients receiving another interventional investigational drug within the 30 days prior to dosing
  • Patients otherwise unsuitable for participation in the opinion of the investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978419


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
  More Information

Publications:
Fogerty MD, Abumrad NN, Guy JS, Efron DT. The Effect of Preinjury Statin Use on Mortality and Sepsis in Elderly Burn Patients. Abstract. Submitted to AAST. 2009

Responsible Party: Mary D. Fogerty, MD, MPH; Assistant Professor of Surgery, Vanderbilt Univeristy
ClinicalTrials.gov Identifier: NCT00978419     History of Changes
Other Study ID Numbers: 091060
First Submitted: September 14, 2009
First Posted: September 16, 2009
Last Update Posted: July 13, 2011
Last Verified: July 2011

Keywords provided by Vanderbilt University:
Statins
Burns
Sedatives
Neurocognitive
Septic
Mortality
C Reactive Protein
Septic shock
Sedation
Neurocognitive function

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors