Statin for Immunomudulation in Sepsis

NCT ID: NCT00452608

Last Updated: 2009-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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amido pill

Group Type PLACEBO_COMPARATOR

amido pill

Intervention Type DRUG

one pill of amido/d by mouth for 10 days

atorvastatina

atrovastatina 80 mg/d by mouth for 10 days

Group Type EXPERIMENTAL

atorvastatina

Intervention Type DRUG

atorvastatina 80 mg/day by mouth for 10 days

Interventions

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amido pill

one pill of amido/d by mouth for 10 days

Intervention Type DRUG

atorvastatina

atorvastatina 80 mg/day by mouth for 10 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Hospital de Clinicas de Porto Alegre

Principal Investigators

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Nadine Clausell

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul - Brazil

Locations

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HCPA - Clinical Hospital fo Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Karen F Prado, investigator

Role: CONTACT

051-98088153 ext. 55

Other Identifiers

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05589

Identifier Type: -

Identifier Source: org_study_id

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