Effect of Rosuvastatin in Abdominal Sepsis

Condition(s) targeted: Sepsis

Intervention: Rosuvastatin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Universidad Autonoma de San Luis Potosí

Official(s) and/or principal investigator(s):
Martin Sanchez-Aguilar, MSc, Principal Investigator, Affiliation: Experimental Surgery , Universidad Autonoma de San Luis Potosi

Overall contact:
Martin Sanchez-Aguilar, MSc, Phone: 524448262345, Email: jemarsan7@hotmail.com

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.

Official title: Use of Rosuvastatin in Integral Management of Abdominal Sepsis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)

Secondary outcome:

Number of survivors

Plasmatic levels of Reactive C Protein (mg/dL)

Classification of severity by APACHE II scale

Incidence of complications or secondary effects

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Martin Sanchez-Aguilar, MSc, Phone: 524448262345, Email: jemarsan7@hotmail.com

Hospital Central "Dr. Ignacio Morones Prieto, San Luis Potosi 78240, Mexico; Recruiting
Lorenzo Guevara-Torres, MD, Sub-Investigator
Jorge H Tapia-Perez, MD, Sub-Investigator
Martin Sanchez-Aguilar, MSc, Sub-Investigator

Starting date: August 2006
Last updated: February 18, 2011