Effect of Rosuvastatin in Abdominal Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Universidad Autonoma de San Luis Potosí

July 26, 2006
July 27, 2006
February 21, 2011
August 2006
July 2011   (Final data collection date for primary outcome measure)
Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL) [ Time Frame: day 3 ]
Classification by APACHE II scale
Complete list of historical versions of study NCT00357123 on Archive Site
  • 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 ]
  • Surviving and stay time (ICU and total in Hospital)
  • Complications
  • RCP
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Effect of Rosuvastatin in Abdominal Sepsis
Use of Rosuvastatin in Integral Management of Abdominal Sepsis
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Drug: Rosuvastatin
20 mg 10 days daily since abdominal sepsis diagnosis
Other Name: Crestor
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
September 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
28-08 ROAS
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UASLP, Martin Sanchez Aguilar
Universidad Autonoma de San Luis Potosí
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Principal Investigator: Martin Sanchez-Aguilar, MSc Experimental Surgery , Universidad Autonoma de San Luis Potosi
Universidad Autonoma de San Luis Potosí
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP