Pilot Trial of Statin Use in Burn Patients (BURNSTAT)

This study has been completed.

Sponsor:

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00978419

First received: September 14, 2009

Last updated: July 12, 2011

Last verified: July 2011

History of Changes

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:

Statin administration within 96 hours of burn is safe, will decrease CRP, and will decrease septic shock and mortality in burn patients.
The investigators hypothesize that burn patients will have a de-novo long term cognitive impairment at 3 months after burn.
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Randomized, Placebo Controlled, Pilot Trial of Statin Use in Burn Patients

Resource links provided by NLM:

MedlinePlus related topics: Burns Delirium Shock Statins

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mortality compared to placebo [ Time Frame: 90 days ] [ Designated as safety issue: No ]
mortality compared to placebo, adjusted for cardiovascular co-morbidities [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Reduction in the incidence of septic shock (see definition) compared to placebo [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Reduction in the incidence of septic shock (see definition) compared to placebo, adjusted for cardiovascular co-morbidities [ Time Frame: 28 days ] [ Designated as safety issue: No ]
A reduction in CK levels over time, compared to placebo measured at baseline and days 3, 7, 14, 21, 28 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
A reduction in ALT levels over time, compared to placebo, measured at baseline, days 1, 7, 14, 21, 28 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Determine the prevalence of delirium in the two subgroup of patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Determine the prevalence of de-novo long-term neurocognitive impairment in burn patients and by study group. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Determine the prevalence of functional impairment in burn patients and by study group [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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 Other Name: Rosuvastatin
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo administered every day for up to 28 days Other Name: Placebo

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978419

Locations

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

More Information

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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
Study First Received:	September 14, 2009
Last Updated:	July 12, 2011
Health Authority:	United States: Institutional Review Board

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013

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