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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 20 mg 10 days daily since abdominal sepsis diagnosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL) | day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of survivors | in-patient follow-up will be considered as well | 1 week after randomization |
| Plasmatic levels of Reactive C Protein (mg/dL) | day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Sanchez-Aguilar, MSc | Contact | 524448262345 | jemarsan7@hotmail.com | |
| Antonio Gordillo-Moscoso, PhD | Contact | 524448262345 | 519 | gordillo@uaslp.mx |
| Name | Affiliation | Role |
|---|---|---|
| Martin Sanchez-Aguilar, MSc | Experimental Surgery , Universidad Autonoma de San Luis Potosi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Central "Dr. Ignacio Morones Prieto | Recruiting | San Luis Potosà City | San Luis Potosà | 78240 | Mexico |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Classification of severity by APACHE II scale | day 3 |
| Incidence of complications or secondary effects | day 1, 3, 7, 14 after randomization |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |