Effect of Rosuvastatin in Abdominal Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
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

July 26, 2006
February 18, 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 ] [ Designated as safety issue: No ]
Classification by APACHE II scale
Complete list of historical versions of study NCT00357123 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Surviving and stay time (ICU and total in Hospital)
  • Complications
  • RCP
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sepsis
Drug: Rosuvastatin
20 mg 10 days daily since abdominal sepsis diagnosis
Other Name: Crestor
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
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
Both
18 Years to 80 Years
No
Contact: Martin Sanchez-Aguilar, MSc 524448262345 jemarsan7@hotmail.com
Contact: Antonio Gordillo-Moscoso, PhD 524448262345 ext 519 gordillo@uaslp.mx
Mexico
 
NCT00357123
28-08 ROAS
Yes
UASLP, Martin Sanchez Aguilar
Universidad Autonoma de San Luis Potosí
Not Provided
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