Statin for Immunomudulation in Sepsis

June 25, 2009 updated by: Hospital de Clinicas de Porto Alegre

Use of Statins in Modulation of Inflammatory Answer in Septic Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • HCPA - Clinical Hospital fo Porto Alegre
        • Sub-Investigator:
          • Karen F Prado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: amido pill
Drug: amido pill
one pill of amido/d by mouth for 10 days
Experimental: atorvastatina
atrovastatina 80 mg/d by mouth for 10 days
Drug: atorvastatina
atorvastatina 80 mg/day by mouth for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
action in inflammmatory biologic makers
Time Frame: 24h; 72h; 10 days
24h; 72h; 10 days
valuation of flow-mediated vasodilation of the brachial artery
Time Frame: 24h; 72; 10 days
24h; 72; 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: at end
at end
time of permanence in intensive care unity
Time Frame: at end
at end
time of permanence in mechanical ventilation
Time Frame: at end
at end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Nadine Clausell, Federal University of Rio Grande do Sul - Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 26, 2007

First Posted (Estimate)

March 27, 2007

Study Record Updates

Last Update Posted (Estimate)

June 26, 2009

Last Update Submitted That Met QC Criteria

June 25, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05589

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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