Effect of Rosuvastatin in Abdominal Sepsis - Full Text View

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

Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL) [ Time Frame: day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of survivors [ Time Frame: 1 week after randomization ] [ Designated as safety issue: No ]
in-patient follow-up will be considered as well
Plasmatic levels of Reactive C Protein (mg/dL) [ Time Frame: day 3 ] [ Designated as safety issue: No ]
Classification of severity by APACHE II scale [ Time Frame: day 3 ] [ Designated as safety issue: No ]
Incidence of complications or secondary effects [ Time Frame: day 1, 3, 7, 14 after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Intervention Details:

20 mg 10 days daily since abdominal sepsis diagnosis

Other Name: Crestor

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.

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 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

Contacts and Locations

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

Contacts

Contact: Martin Sanchez-Aguilar, MSc	524448262345	jemarsan7@hotmail.com
Contact: Antonio Gordillo-Moscoso, PhD	524448262345 ext 519	gordillo@uaslp.mx

Locations

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

Sponsors and Collaborators

Universidad Autonoma de San Luis Potosí

Investigators

Principal Investigator:

Martin Sanchez-Aguilar, MSc

Experimental Surgery , Universidad Autonoma de San Luis Potosi

More Information

No publications provided

Responsible Party:	UASLP, Martin Sanchez Aguilar
ClinicalTrials.gov Identifier:	NCT00357123 History of Changes
Other Study ID Numbers:	28-08 ROAS
Study First Received:	July 26, 2006
Last Updated:	February 18, 2011
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Universidad Autonoma de San Luis Potosí:

abdominal sepsis
sepsis
rosuvastatin

Additional relevant MeSH terms:

Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012