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Effect of Rosuvastatin in Abdominal Sepsis

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ClinicalTrials.gov Identifier: NCT00357123
Recruitment Status : Unknown
Verified September 2010 by Universidad Autonoma de San Luis Potosí.
Recruitment status was:  Recruiting
First Posted : July 27, 2006
Last Update Posted : February 21, 2011
Sponsor:
Information provided by:
Universidad Autonoma de San Luis Potosí

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Rosuvastatin Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : August 2006
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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Intervention Details:
  • Drug: Rosuvastatin
    20 mg 10 days daily since abdominal sepsis diagnosis
    Other Name: Crestor

Outcome Measures
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Primary Outcome Measures :
  1. Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL) [ Time Frame: day 3 ]

Secondary Outcome Measures :
  1. Number of survivors [ Time Frame: 1 week after randomization ]
    in-patient follow-up will be considered as well

  2. Plasmatic levels of Reactive C Protein (mg/dL) [ Time Frame: day 3 ]
  3. Classification of severity by APACHE II scale [ Time Frame: day 3 ]
  4. Incidence of complications or secondary effects [ Time Frame: day 1, 3, 7, 14 after randomization ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357123


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

Locations
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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
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Principal Investigator: Martin Sanchez-Aguilar, MSc Experimental Surgery , Universidad Autonoma de San Luis Potosi
More Information
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Responsible Party: UASLP, Martin Sanchez Aguilar
ClinicalTrials.gov Identifier: NCT00357123    
Other Study ID Numbers: 28-08 ROAS
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: September 2010
Keywords provided by Universidad Autonoma de San Luis Potosí:
abdominal sepsis
sepsis
rosuvastatin
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Rosuvastatin Calcium
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors