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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
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
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:
    Drug: Rosuvastatin
    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)
Genders Eligible for Study:   Both
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
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
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

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 23, 2016