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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
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00452608
First received: March 26, 2007
Last updated: June 25, 2009
Last verified: June 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Sepsis
 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:

MedlinePlus related topics: Sepsis Statins
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452608

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

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

No publications provided

Responsible Party: Nadine Clausell, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov 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:
Sepsis
Toxemia
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013