We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Statin for Immunomudulation in Sepsis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00452608
First Posted: March 27, 2007
Last Update Posted: June 26, 2009
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.
Information provided by:
Hospital de Clinicas de Porto Alegre
  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
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

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 ]
  • valuation of flow-mediated vasodilation of the brachial artery [ Time Frame: 24h; 72; 10 days ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
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
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
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

Responsible Party: Nadine Clausell, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00452608     History of Changes
Other Study ID Numbers: 05589
First Submitted: March 26, 2007
First Posted: March 27, 2007
Last Update Posted: June 26, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes