Effect of Rosuvastatin in Abdominal Sepsis
Recruitment status was Recruiting
The purpose of this study is to determine whether rosuvastatin is effective as a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Use of Rosuvastatin in Integral Management of Abdominal Sepsis|
- Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL) [ Time Frame: day 3 ] [ Designated as safety issue: No ]
- Number of survivors [ Time Frame: 1 week after randomization ] [ Designated as safety issue: No ]in-patient follow-up will be considered as well
- Plasmatic levels of Reactive C Protein (mg/dL) [ Time Frame: day 3 ] [ Designated as safety issue: No ]
- Classification of severity by APACHE II scale [ Time Frame: day 3 ] [ Designated as safety issue: No ]
- Incidence of complications or secondary effects [ Time Frame: day 1, 3, 7, 14 after randomization ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|