Effect of Rosuvastatin in Abdominal Sepsis

Sepsis Clinical Trial

Official title:

Use of Rosuvastatin in Integral Management of Abdominal Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00357123
• Other study ID #: 28-08 ROAS
• Status: Recruiting
• Phase: Phase 2
• First received: July 26, 2006
• Last updated: February 18, 2011
• Start date: August 2006
• Est. completion date: September 2011

Study information

• Verified date: September 2010
• Source: Universidad Autonoma de San Luis Potosí
• Contact: Martin Sanchez-Aguilar, MSc
• Phone: 524448262345
• Email: jemarsan7[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Central "Dr. Ignacio Morones Prieto	San Luis Potosi

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)		day 3	No
Secondary	Number of survivors	in-patient follow-up will be considered as well	1 week after randomization	No
Secondary	Plasmatic levels of Reactive C Protein (mg/dL)		day 3	No
Secondary	Classification of severity by APACHE II scale		day 3	No
Secondary	Incidence of complications or secondary effects		day 1, 3, 7, 14 after randomization	Yes