Sepsis
Conditions
Keywords
abdominal sepsis, sepsis, rosuvastatin
Brief summary
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.
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.
Interventions
DRUGRosuvastatin
20 mg 10 days daily since abdominal sepsis diagnosis
Sponsors
Universidad Autonoma de San Luis Potosí
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL) | day 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of survivors | 1 week after randomization | in-patient follow-up will be considered as well |
| Plasmatic levels of Reactive C Protein (mg/dL) | day 3 | — |
| Classification of severity by APACHE II scale | day 3 | — |
| Incidence of complications or secondary effects | day 1, 3, 7, 14 after randomization | — |
Countries
Mexico
Contacts
Primary ContactMartin Sanchez-Aguilar, MSc
Backup ContactAntonio Gordillo-Moscoso, PhD
Outcome results
None listed