Effect of Rosuvastatin in Abdominal Sepsis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2010 by Universidad Autonoma de San Luis Potosí.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Universidad Autonoma de San Luis Potosí

ClinicalTrials.gov Identifier:

NCT00357123

First received: July 26, 2006

Last updated: February 18, 2011

Last verified: September 2010

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:

Number of survivors [ Time Frame: 1 week after randomization ]
in-patient follow-up will be considered as well
Plasmatic levels of Reactive C Protein (mg/dL) [ Time Frame: day 3 ]
Classification of severity by APACHE II scale [ Time Frame: day 3 ]
Incidence of complications or secondary effects [ Time Frame: day 1, 3, 7, 14 after randomization ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

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 Calcium	Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 21, 2017

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