Statin for Immunomudulation in Sepsis

Phase 2

• Conditions: Sepsis
• Interventions: Drug: amido pill; Drug: atorvastatina

• Registration Number: NCT00452608
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-03-26
• Study First Submitted QC: 2007-03-26
• Study First Posted: 2007-03-27
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-25
• Last Update Posted: 2009-06-26
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amido pill	amido pill	-
atorvastatina	atorvastatina	atrovastatina 80 mg/d by mouth for 10 days

Primary Outcome Measures

Name	Time	Method
action in inflammmatory biologic makers	24h; 72h; 10 days
valuation of flow-mediated vasodilation of the brachial artery	24h; 72; 10 days

Secondary Outcome Measures

Name	Time	Method
mortality	at end
time of permanence in intensive care unity	at end
time of permanence in mechanical ventilation	at end

Trial Locations

Locations (1)

HCPA - Clinical Hospital fo Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil