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Statin for Immunomudulation in Sepsis

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ClinicalTrials.gov Identifier: NCT00452608
Recruitment Status : Unknown
Verified June 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : March 27, 2007
Last Update Posted : June 26, 2009
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

Study Description
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Brief Summary:
The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients

Condition or disease Intervention/treatment Phase
Sepsis Drug: amido pill Drug: atorvastatina Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Statins in Modulation of Inflammatory Answer in Septic Patients
Study Start Date : December 2006
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Statins

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. action in inflammmatory biologic makers [ Time Frame: 24h; 72h; 10 days ]
  2. valuation of flow-mediated vasodilation of the brachial artery [ Time Frame: 24h; 72; 10 days ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: at end ]
  2. time of permanence in intensive care unity [ Time Frame: at end ]
  3. time of permanence in mechanical ventilation [ Time Frame: at end ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452608


Contacts
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Contact: Karen F Prado, investigator 051-98088153 ext 55 karen@portoweb.com.br

Locations
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Brazil
HCPA - Clinical Hospital fo Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sub-Investigator: Karen F Prado         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Nadine Clausell Federal University of Rio Grande do Sul - Brazil
More Information
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Responsible Party: Nadine Clausell, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00452608    
Other Study ID Numbers: 05589
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: June 26, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Atorvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors