Effect of Rosuvastatin in Abdominal Sepsis
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|ClinicalTrials.gov Identifier: NCT00357123|
Recruitment Status : Unknown
Verified September 2010 by Universidad Autonoma de San Luis Potosí.
Recruitment status was: Recruiting
First Posted : July 27, 2006
Last Update Posted : February 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Drug: Rosuvastatin||Phase 2|
The sepsis is often lethal, the mortality's ranks are identified among 25 to 70%, this depends on definition, severity and co-morbidities. The number of deaths by sepsis could be similar to myocardial infarct. Patients who get shock have 26-fold risk of death.
In preliminary studies have been observed, that patients with treatment with statin have minor incidence of severe sepsis. A retrospective study suggests the association between using statins and reduction of bacteriemia by Gram negatives and S. aureus.
There are many experimental studies which demonstrate the possible profit in sepsis. However there are no clinical prospective studies for determinate if statins are effective in management of sepsis. The investigators designed this study to demonstrate the utility of rosuvastatin in one kind of sepsis, abdominal sepsis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Use of Rosuvastatin in Integral Management of Abdominal Sepsis|
|Study Start Date :||August 2006|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||September 2011|
- Drug: Rosuvastatin
20 mg 10 days daily since abdominal sepsis diagnosisOther Name: Crestor
- Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL) [ Time Frame: day 3 ]
- Number of survivors [ Time Frame: 1 week after randomization ]in-patient follow-up will be considered as well
- Plasmatic levels of Reactive C Protein (mg/dL) [ Time Frame: day 3 ]
- Classification of severity by APACHE II scale [ Time Frame: day 3 ]
- Incidence of complications or secondary effects [ Time Frame: day 1, 3, 7, 14 after randomization ]
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): NCT00357123
|Contact: Martin Sanchez-Aguilar, MScfirstname.lastname@example.org|
|Contact: Antonio Gordillo-Moscoso, PhD||524448262345 ext email@example.com|
|Hospital Central "Dr. Ignacio Morones Prieto||Recruiting|
|San Luis Potosi, Mexico, 78240|
|Sub-Investigator: Lorenzo Guevara-Torres, MD|
|Sub-Investigator: Jorge H Tapia-Perez, MD|
|Sub-Investigator: Martin Sanchez-Aguilar, MSc|
|Principal Investigator:||Martin Sanchez-Aguilar, MSc||Experimental Surgery , Universidad Autonoma de San Luis Potosi|