Effect of Rosuvastatin in Abdominal Sepsis

Use of Rosuvastatin in Integral Management of Abdominal Sepsis

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis
• Intervention / Treatment: Drug: Rosuvastatin

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Martin Sanchez-Aguilar, MSc; Phone Number: 524448262345; Email: jemarsan7@hotmail.com
• Study Contact Backup: Name: Antonio Gordillo-Moscoso, PhD; Phone Number: 519 524448262345; Email: gordillo@uaslp.mx

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universidad Autonoma de San Luis Potosí
• Investigators: Principal Investigator: Martin Sanchez-Aguilar, MSc, Experimental Surgery , Universidad Autonoma de San Luis Potosi

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: July 26, 2006
• First Submitted That Met QC Criteria: July 26, 2006
• First Posted (Estimate): July 27, 2006

Study Record Updates

• Last Update Posted (Estimate): February 21, 2011
• Last Update Submitted That Met QC Criteria: February 18, 2011
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: sepsis; rosuvastatin; abdominal sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Intraabdominal Infections; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: 28-08 ROAS