Official Title: “Use of Rosuvastatin in Integral Management of Abdominal Sepsis”

The purpose of this study is to determine whether rosuvastatin is effective such a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: October 2007

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 suggest 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. We design this study for demonstrate the utility if rosuvastatin in one kind of sepsis, abdominal sepsis.

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
  • 20 mg 10 days daily since abdominal sepsis diagnosis

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: B

Primary Measures

• Classification by APACHE II scale
  • Time Frame: 0,1,3,10 day
    Safety Issue?: Yes
• Cytokines IL6, IL 1B, TNF alpha
  • Time Frame: basal and third day
    Safety Issue?: No

Secondary Measures

• Surviving
  • Time Frame: stay time
    Safety Issue?: No
• RCP
  • Time Frame: basal, 3 and 10 day
    Safety Issue?: No

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 o 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Universidad Autonoma de San Luis Potosí

Overall Clinical Trial Officials and Contacts

Fatima Ortiz-Castillo, MD Principal Investigator Surgery Division, "Hospital Central "Dr. Ignacio Morones Prieto"  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00357123

Study ID Number: 28-08 ROAS

ClinicalTrials.gov Identifier: NCT00357123

Health Authority: Mexico: National Institute of Public Health, Health Secretariat