Statin for Immunomudulation in Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
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

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

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

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

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 ]

Information from the National Library of Medicine

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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

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

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 identifier (NCT number): NCT00452608

Contact: Karen F Prado, investigator 051-98088153 ext 55

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

Responsible Party: Nadine Clausell, Hospital de Clinicas de Porto Alegre Identifier: NCT00452608     History of Changes
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:
Systemic Inflammatory Response Syndrome
Pathologic Processes