Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia

• Status: Completed
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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 including pneumonia.

This study aims to determine whether adjunctive statin therapy decreased day- 28 mortality among ICU patients with ventilator-associated pneumonia (VAP) & number of ventilator-free days (after successful weaning) between day 1 and both day 28.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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