Statin for Immunomudulation in Sepsis

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 2

Conditions: Sepsis

Treatments: Drug: amido pill; Drug: atorvastatina

Study type: Interventional

Funder types: Other

Identifiers

NCT00452608

05589

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

amido pill

Placebo Comparator group

Treatment:

Drug: amido pill

atorvastatina

Experimental group

Description:

atrovastatina 80 mg/d by mouth for 10 days

Treatment:

Drug: atorvastatina