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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00357123 |
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Date of registration:
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26/07/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Rosuvastatin in Abdominal Sepsis
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Scientific title:
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Use of Rosuvastatin in Integral Management of Abdominal Sepsis |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00357123 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Martin Sanchez-Aguilar, MSc |
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Address:
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Telephone:
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524448262345 |
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Email:
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jemarsan7@hotmail.com |
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Affiliation:
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Name:
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Martin Sanchez-Aguilar, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Experimental Surgery , Universidad Autonoma de San Luis Potosi |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sepsis
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Intervention(s)
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Drug: Rosuvastatin
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Primary Outcome(s)
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Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)
[Time Frame: day 3]
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Secondary Outcome(s)
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Incidence of complications or secondary effects
[Time Frame: day 1, 3, 7, 14 after randomization]
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Classification of severity by APACHE II scale
[Time Frame: day 3]
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Number of survivors
[Time Frame: 1 week after randomization]
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Plasmatic levels of Reactive C Protein (mg/dL)
[Time Frame: day 3]
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Secondary ID(s)
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28-08 ROAS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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