Phase 2
N=40
Pilot Trial of Statin Use in Burn Patients
Burns
Bottom Line
View on ClinicalTrials.gov: NCT00978419 ↗Enrolled (actual)
40
Serious AEs
—
Results posted
Jun 2018
Primary outcome: Primary: 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.
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rosuvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
— | — |
| SECONDARY Mortality Compared to Placebo |
— | — |
| SECONDARY Mortality Compared to Placebo, Adjusted for Cardiovascular Co-morbidities |
— | — |
| SECONDARY Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo |
— | — |
| SECONDARY Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo, Adjusted for Cardiovascular Co-morbidities |
— | — |
| SECONDARY A Reduction in CK Levels Over Time, Compared to Placebo Measured at Baseline and Days 3, 7, 14, 21, 28 |
— | — |
| SECONDARY A Reduction in ALT Levels Over Time, Compared to Placebo, Measured at Baseline, Days 1, 7, 14, 21, 28 |
— | — |
| SECONDARY Determine the Safety of Rosuvastatin Compared to Placebo in Burn Patients by Comparing the Frequency, Type and Severity of Adverse Events |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Determine the Prevalence of Delirium in the Two Subgroup of Patients |
— | — |
| SECONDARY Determine the Prevalence of De-novo Long-term Neurocognitive Impairment in Burn Patients and by Study Group. |
— | — |
| SECONDARY Determine the Prevalence of Functional Impairment in Burn Patients and by Study Group |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00978419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.