Pilot Trial of Statin Use in Burn Patients

NCT00978419 | Completed Phase 2 Results DMC

• 1 other identifier: 091060
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Statins; Burns; Sedatives; Neurocognitive; Septic; Mortality; C Reactive Protein; Septic shock; Sedation; Neurocognitive function

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 1, 3, 7, 14

Secondary Outcomes (11)

• Mortality Compared to Placebo

  90 days

• Mortality Compared to Placebo, Adjusted for Cardiovascular Co-morbidities

  90 days

• Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo

  28 days

• Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo, Adjusted for Cardiovascular Co-morbidities

  28 days

• A Reduction in CK Levels Over Time, Compared to Placebo Measured at Baseline and Days 3, 7, 14, 21, 28

  28 days

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin

Drug: Rosuvastatin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Rosuvastatin DRUG

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

Rosuvastatin

Placebo DRUG

Placebo administered every day for up to 28 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thermal burn occurring within the 96 hours prior to dosing

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (49)

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MeSH Terms

Conditions

Burns; Shock, Septic

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Wounds and Injuries; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Burn Unit Director
• Organization: Vanderbilt University Medical Center

(615) 322-4590

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 16, 2009
• Study Start: March 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 1, 2018
• Results First Posted: June 1, 2018

Record last verified: 2018-04

Locations

US (1)