NCT00452608UnknownPhase 2
Use of Statins in Modulation of Inflammatory Answer in Septic Patients
Hospital de Clinicas de Porto Alegre1 site in 1 country80 target enrollmentStarted: December 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- action in inflammmatory biologic makers
Study Overview
Brief Summary
The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinical diagnosis of several sepsis or shock septic
- •no more than twenty four hours than diagnosis
Exclusion Criteria
- •use of statins in the last thirty days
- •unequivocal indication for statin treatment
- •active treatment with imunosuppressors drugs
- •High risk of rhabdomyolysis: multiple trauma, crush injuries, baseline creatinine kinase > three times upper limit of normal
- •diagnosis of AIDS
- •unable to receive enteral medications
- •pregnancy
- •expected survival of less than 48 hours
Arms & Interventions
amido pill
Placebo Comparator
Intervention: amido pill (Drug)
atorvastatina
Experimental
atrovastatina 80 mg/d by mouth for 10 days
Intervention: atorvastatina (Drug)
Outcomes
Primary Outcomes
action in inflammmatory biologic makers
Time Frame: 24h; 72h; 10 days
valuation of flow-mediated vasodilation of the brachial artery
Time Frame: 24h; 72; 10 days
Secondary Outcomes
- mortality(at end)
- time of permanence in intensive care unity(at end)
- time of permanence in mechanical ventilation(at end)
Investigators
Study Sites (1)
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