Effect of Rosuvastatin in Abdominal Sepsis

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

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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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

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Responsible Party:	UASLP, Martin Sanchez Aguilar
ClinicalTrials.gov Identifier:	NCT00357123 History of Changes
Other Study ID Numbers:	28-08 ROAS
First Posted:	July 27, 2006
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:

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