Statin for Immunomudulation in Sepsis

Sepsis Clinical Trial

Official title:

Use of Statins in Modulation of Inflammatory Answer in Septic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00452608
• Other study ID #: 05589
• Status: Recruiting
• Phase: Phase 2
• First received: March 26, 2007
• Last updated: June 25, 2009
• Start date: December 2006
• Est. completion date: December 2009

Study information

• Verified date: June 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Karen F Prado, investigator
• Phone: 051-98088153
• Email: karen[@]portoweb.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis

Intervention

Drug:
• amido pill
one pill of amido/d by mouth for 10 days
• atorvastatina
atorvastatina 80 mg/day by mouth for 10 days

Locations

Country	Name	City	State
Brazil	HCPA - Clinical Hospital fo Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	action in inflammmatory biologic makers		24h; 72h; 10 days	Yes
Primary	valuation of flow-mediated vasodilation of the brachial artery		24h; 72; 10 days	Yes
Secondary	mortality		at end	Yes
Secondary	time of permanence in intensive care unity		at end	Yes
Secondary	time of permanence in mechanical ventilation		at end	Yes