Effect of Rosuvastatin in Abdominal Sepsis

Phase 2

• Conditions: Sepsis

• Registration Number: NCT00357123
• Lead Sponsor: Universidad Autonoma de San Luis Potosí

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.

Study Timeline

• Study First Submitted: 2006-07-26
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Study Start: 2006-08
• Status Verified: 2010-09
• Last Update Submitted: 2011-02-18
• Last Update Posted: 2011-02-21
• Primary Completion: 2011-07
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)	day 3

Secondary Outcome Measures

Name	Time	Method
Number of survivors	1 week after randomization	in-patient follow-up will be considered as well
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

Trial Locations

Locations (1)

Hospital Central "Dr. Ignacio Morones Prieto; 🇲🇽 San Luis Potosi, Mexico