Effect of Rosuvastatin in Abdominal Sepsis
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sepsis | Drug: Rosuvastatin | Phase 2 |
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 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 |
- Drug: Rosuvastatin
20 mg 10 days daily since abdominal sepsis diagnosisOther Name: Crestor
- Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL) [ Time Frame: day 3 ]
- 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 ]

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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 |
Inclusion Criteria:
- Man or women > 18 and < 80 years old with abdominal sepsis, confirmed diagnosis by surgery of broad peritonitis before 48 hours in progression
- Injury by steel or firearm with contaminated abdominal cavity
- APACHE II major or equal than 8
- Acceptance to be included
Exclusion Criteria:
- Ingestion of: fibrates, niacin, cyclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone
- Hypovolemic shock III and IV after get surgery
- Cardio-respiratory failure pre or trans surgery
- Allergy to used drug
- Use previous of statin
- Hepatopathy or myopathy and(or) history, hepatic failure (Child B y C)
- Management in other Hospital
- Pregnancy
- Thoracic injury, head injury (moderate and severe), multiple fractures or with bone exposition, rectal injury

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357123
Contact: Martin Sanchez-Aguilar, MSc | 524448262345 | jemarsan7@hotmail.com | |
Contact: Antonio Gordillo-Moscoso, PhD | 524448262345 ext 519 | gordillo@uaslp.mx |
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 |
Principal Investigator: | Martin Sanchez-Aguilar, MSc | Experimental Surgery , Universidad Autonoma de San Luis Potosi |
Responsible Party: | UASLP, Martin Sanchez Aguilar |
ClinicalTrials.gov Identifier: | NCT00357123 |
Other Study ID Numbers: |
28-08 ROAS |
First Posted: | July 27, 2006 Key Record Dates |
Last Update Posted: | February 21, 2011 |
Last Verified: | September 2010 |
abdominal sepsis sepsis rosuvastatin |
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 |