Effect of Rosuvastatin in Abdominal Sepsis - Full Text View

Sponsored by:	Universidad Autonoma de San Luis Potosí
Information provided by:	Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:	NCT00357123

Purpose

The purpose of this study is to determine whether rosuvastatin is effective such a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery.

Condition	Intervention	Phase
Sepsis	Drug: Rosuvastatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Use of Rosuvastatin in Integral Management of Abdominal Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:

Cytokines IL6, IL 1B, TNF alpha [ Time Frame: basal and third day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Surviving [ Time Frame: stay time ] [ Designated as safety issue: No ]
RCP [ Time Frame: basal, 3 and 10 day ] [ Designated as safety issue: No ]
Classification by APACHE II scale [ Time Frame: 0,1,3,7,10 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	August 2006
Estimated Study Completion Date:	June 2009
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Intervention Details:

20 mg 10 days daily since abdominal sepsis diagnosis

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 suggest 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. We design this study for demonstrate the utility if rosuvastatin in one kind of sepsis, abdominal sepsis.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 o 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357123

Contacts

Contact: Fatima Ortiz-Castillo, MD	524448037456
Contact: Martin Sanchez-Aguilar, Maester	524448262345 ext 519	jemarsan7@hotmail.com

Locations

Mexico
Hospital Central "Dr. Ignacio Morones Prieto	Recruiting
San Luis Potosi, Mexico, 78240
Principal Investigator: Fatima Ortiz-Castillo, MD
Sub-Investigator: Lorenzo Guevara-Torres, MD
Sub-Investigator: Humberto Tapia-Perez, MD
Sub-Investigator: Martin Sanchez-Aguilar, Maester

Sponsors and Collaborators

Universidad Autonoma de San Luis Potosí

Investigators

Principal Investigator:

Fatima Ortiz-Castillo, MD

Surgery Division, "Hospital Central "Dr. Ignacio Morones Prieto"

More Information

No publications provided

Responsible Party:	Martin Sanchez Aguilar ( UASLP )
Study ID Numbers:	28-08 ROAS
Study First Received:	July 26, 2006
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00357123 History of Changes
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Universidad Autonoma de San Luis Potosí:

abdominal sepsis
sepsis
rosuvastatin

Study placed in the following topic categories:

Antimetabolites
Systemic Inflammatory Response Syndrome
Sepsis
Rosuvastatin

Antilipemic Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Infection

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Inflammation
Sepsis
Pathologic Processes
Rosuvastatin
Therapeutic Uses

ClinicalTrials.gov processed this record on September 10, 2009