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Statin for Immunomudulation in Sepsis

Use of Statins in Modulation of Inflammatory Answer in Septic Patients

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00452608
Enrollment
80
Registered
2007-03-27
Start date
2006-12-31
Completion date
2009-12-31
Last updated
2009-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Brief summary

The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients

Interventions

DRUGamido pill

one pill of amido/d by mouth for 10 days

DRUGatorvastatina

atorvastatina 80 mg/day by mouth for 10 days

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
action in inflammmatory biologic makers24h; 72h; 10 days
valuation of flow-mediated vasodilation of the brachial artery24h; 72; 10 days

Secondary

MeasureTime frame
mortalityat end
time of permanence in intensive care unityat end
time of permanence in mechanical ventilationat end

Countries

Brazil

Contacts

Primary ContactKaren F Prado, investigator
karen@portoweb.com.br051-98088153

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026