Effect of Rosuvastatin in Abdominal Sepsis

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Use of Rosuvastatin in Integral Management of Abdominal Sepsis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or women > 18 and < 80 years old with abdominal sepsis, confirmed diagnosis by surgery of broad peritonitis before 48 hours in progression Injury by steel or firearm with contaminated abdominal cavity APACHE II major or equal than 8 Acceptance to be included Exclusion Criteria: Ingestion of: fibrates, niacin, cyclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone Hypovolemic shock III and IV after get surgery Cardio-respiratory failure pre or trans surgery Allergy to used drug Use previous of statin Hepatopathy or myopathy and(or) history, hepatic failure (Child B y C) Management in other Hospital Pregnancy Thoracic injury, head injury (moderate and severe), multiple fractures or with bone exposition, rectal injury

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|20 mg 10 days daily since abdominal sepsis diagnosis|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL) |  | day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of survivors | in-patient follow-up will be considered as well | 1 week after randomization | 
| Plasmatic levels of Reactive C Protein (mg/dL) |  | day 3 | 
| Classification of severity by APACHE II scale |  | day 3 | 
| Incidence of complications or secondary effects |  | day 1, 3, 7, 14 after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal sepsis, sepsis, rosuvastatin