Clinical trial NCT00357123: Effect of Rosuvastatin in Abdominal Sepsis
Official title: Use of Rosuvastatin in Integral Management of Abdominal Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sepsis
Keywords: abdominal sepsis
sepsis
rosuvastatin
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2006-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)
timeFrame: day 3
Secondary outcomes:
measure: Number of survivors
timeFrame: 1 week after randomization
measure: Plasmatic levels of Reactive C Protein (mg/dL)
timeFrame: day 3
measure: Classification of severity by APACHE II scale
timeFrame: day 3
measure: Incidence of complications or secondary effects
timeFrame: day 1, 3, 7, 14 after randomization
Other outcomes:
Locations:
city: San Luis Potosi
country: Mexico
facility: Hospital Central "Dr. Ignacio Morones Prieto
Study officials:
affiliation: Experimental Surgery , Universidad Autonoma de San Luis Potosi
name: Martin Sanchez-Aguilar, MSc
role: PRINCIPAL_INVESTIGATOR
References: