Status:
COMPLETED
Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia
Lead Sponsor:
Ain Shams University
Conditions:
VAP - Ventilator Associated Pneumonia
Eligibility:
All Genders
29-71 years
Phase:
PHASE4
Brief Summary
Statins with their powerful anti-inflammatory, immunomodulatory, and antioxidant properties make them candidate members to be used in the management of sepsis and different types of infections includi...
Detailed Description
This prospective randomized control-controlled triple blind study was conducted on above 18 years who had received mechanical ventilation in the ICU for at least 2 days. All included cases were subje...
Eligibility Criteria
Inclusion
- Patients who suspected to had VAP defined as a modified Clinical Pulmonary Infection Score (CPIS) of at least 5 and if they underwent quantitative bacteriological cultures of bronchoalveolar lavage (BAL) fluid, a protected telescopic catheter (PTC), or an endotracheal aspirate. The modified CPIS is based on body temperature, blood leukocyte count, amount and appearance of tracheal secretions, ratio of partial pressure of oxygen (PaO2) to fraction of inspired oxygen, acute respiratory distress syndrome (ARDS), and infiltrates on chest radiography. The total can range from 1 to 10 points (Luna et al., 2003).
- Patients were included only for the first episode of suspected VAP.
Exclusion
- o Statin therapy at intubation
- Previous VAP episode during the same hospitalization
- Known pregnancy
- Immunodepression with bone marrow aplasia
- Imminent death (Simplified Acute Physiology Score II of 75 or greater, calculated over the last 6 hours)
- Treatment limitation decisions
- Nothing-by-mouth order and no nasogastric tube, continuous gastric aspiration
- Known chronic intestinal malabsorption
- Known simvastatin hypersensitivity
- Acute hepatic failure
- Use of CYP3A4 inhibitors or cyclosporine
- Creatine kinase level greater than 5 times the upper limit of normal
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT05230472
Start Date
January 1 2021
End Date
February 1 2022
Last Update
February 9 2022
Active Locations (1)
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1
Ain Shams University
Cairo, Egypt, 11311