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Statin for Immunomudulation in Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Information provided by:
Hospital de Clinicas de Porto Alegre Identifier:
First received: March 26, 2007
Last updated: June 25, 2009
Last verified: June 2009
The purpose of this study is to determine whether atorvastatin can improve the inflammatory answer in the septic patients

Condition Intervention Phase
Drug: amido pill
Drug: atorvastatina
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Statins in Modulation of Inflammatory Answer in Septic Patients

Resource links provided by NLM:

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • action in inflammmatory biologic makers [ Time Frame: 24h; 72h; 10 days ] [ Designated as safety issue: Yes ]
  • valuation of flow-mediated vasodilation of the brachial artery [ Time Frame: 24h; 72; 10 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mortality [ Time Frame: at end ] [ Designated as safety issue: Yes ]
  • time of permanence in intensive care unity [ Time Frame: at end ] [ Designated as safety issue: Yes ]
  • time of permanence in mechanical ventilation [ Time Frame: at end ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: December 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Nadine Clausell, Hospital de Clinicas de Porto Alegre Identifier: NCT00452608     History of Changes
Other Study ID Numbers: 05589 
Study First Received: March 26, 2007
Last Updated: June 25, 2009
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes processed this record on October 27, 2016