Use of Rosuvastatin in Integral Management of Abdominal Sepsis
18 Years
80 Years
Both
Sepsis
Trial Information
Use of Rosuvastatin in Integral Management of Abdominal Sepsis
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.
Inclusion Criteria:
1. Man or women > 18 and < 80 years old with abdominal sepsis, confirmed diagnosis by
surgery of broad peritonitis before 48 hours in progression
2. Injury by steel or firearm with contaminated abdominal cavity
3. APACHE II major or equal than 8
4. Acceptance to be included
Exclusion Criteria:
1. Ingestion of: fibrates, niacin, cyclosporin, azoles, macrolides, inhibitors of
protease, nefazodone, verapamil, diltiazem, amiodarone
2. Hypovolemic shock III and IV after get surgery
3. Cardio-respiratory failure pre or trans surgery
4. Allergy to used drug
5. Use previous of statin
6. Hepatopathy or myopathy and(or) history, hepatic failure (Child B y C)
7. Management in other Hospital
8. Pregnancy
9. Thoracic injury, head injury (moderate and severe), multiple fractures or with bone
exposition, rectal injury
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)
Outcome Time Frame:
day 3
Safety Issue:
No
Principal Investigator
Martin Sanchez-Aguilar, MSc
Investigator Role:
Principal Investigator
Investigator Affiliation:
Experimental Surgery , Universidad Autonoma de San Luis Potosi
Authority:
Mexico: National Institute of Public Health, Health Secretariat
Study ID:
28-08 ROAS
NCT ID:
NCT00357123
Start Date:
August 2006
Completion Date:
September 2011
Related Keywords:
- Sepsis
- abdominal sepsis
- sepsis
- rosuvastatin
- Sepsis
- Toxemia
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