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
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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 |

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
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Drug: atorvastatina
atorvastatina 80 mg/day by mouth for 10 days |
- 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 ]
- 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 ]

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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

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
Contact: Karen F Prado, investigator | 051-98088153 ext 55 | karen@portoweb.com.br |
Brazil | |
HCPA - Clinical Hospital fo Porto Alegre | Recruiting |
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903 | |
Sub-Investigator: Karen F Prado |
Principal Investigator: | Nadine Clausell | Federal University of Rio Grande do Sul - Brazil |
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 |
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 |