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Effect of Rosuvastatin in Abdominal Sepsis

Primary Purpose

Sepsis

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
Universidad Autonoma de San Luis Potosí
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring abdominal sepsis, sepsis, rosuvastatin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Central "Dr. Ignacio Morones PrietoRecruiting

Outcomes

Primary Outcome Measures

Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)

Secondary Outcome Measures

Number of survivors
in-patient follow-up will be considered as well
Plasmatic levels of Reactive C Protein (mg/dL)
Classification of severity by APACHE II scale
Incidence of complications or secondary effects

Full Information

First Posted
July 26, 2006
Last Updated
February 18, 2011
Sponsor
Universidad Autonoma de San Luis Potosí
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1. Study Identification

Unique Protocol Identification Number
NCT00357123
Brief Title
Effect of Rosuvastatin in Abdominal Sepsis
Official Title
Use of Rosuvastatin in Integral Management of Abdominal Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad Autonoma de San Luis Potosí

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
abdominal sepsis, sepsis, rosuvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
20 mg 10 days daily since abdominal sepsis diagnosis
Primary Outcome Measure Information:
Title
Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)
Time Frame
day 3
Secondary Outcome Measure Information:
Title
Number of survivors
Description
in-patient follow-up will be considered as well
Time Frame
1 week after randomization
Title
Plasmatic levels of Reactive C Protein (mg/dL)
Time Frame
day 3
Title
Classification of severity by APACHE II scale
Time Frame
day 3
Title
Incidence of complications or secondary effects
Time Frame
day 1, 3, 7, 14 after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Sanchez-Aguilar, MSc
Phone
524448262345
Email
jemarsan7@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Gordillo-Moscoso, PhD
Phone
524448262345
Ext
519
Email
gordillo@uaslp.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Sanchez-Aguilar, MSc
Organizational Affiliation
Experimental Surgery , Universidad Autonoma de San Luis Potosi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Central "Dr. Ignacio Morones Prieto
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Guevara-Torres, MD
First Name & Middle Initial & Last Name & Degree
Jorge H Tapia-Perez, MD
First Name & Middle Initial & Last Name & Degree
Martin Sanchez-Aguilar, MSc

12. IPD Sharing Statement

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Effect of Rosuvastatin in Abdominal Sepsis

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