Pravastatin and Ventilatory Associated Pneumonia

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Statins present anti-inflammatory and immunomodulatory effects. They may modify the regulation of cytokines, (released from the cellular damage) and may reduce the production of C-reactive protein levels. It has been hypothesized that these pleiotropic characteristic of statins might be useful in the management of various diseases, including pneumonia. Indeed, a recent study showed that statin treatment is associated with reduced risk of pneumonia in diabetic patients. However, the relationship between statins and reduced risk of pneumonia is not consistent . In addition there is no prospective study to investigate the role of statins in severe forms of pneumonia such as the VAP.

On this base the investigators aim to study prospectively the effect of statins on the outcome of patients with VAP in the ICU settings. The investigators therefore contacted a double open label randomized trial to investigate whether the use of pravastatin reduces the incidence of Ventilator Associated Pneumonia in the ICU and whether it is related with favorable outcome of patients with Ventilator Associated Pneumonia.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Thessaly
• Treatments: Pravastatin

Criteria

Inclusion Criteria:

• Presence in Intensive Care Unit

Exclusion Criteria:

• Pregnancy,

• Pneumonia, previous use of statins,

• Contraindications to statin use (liver dysfunction, SGOT/SGPT > 100 U/L),

• Increased CPK (over 3 times the upper limit), (for non trauma patients) on admission,

• Increase of CPK (over 5 times the upper limit) during hospitalization,

• Use of substances that contraindicates simultaneous use of statins (macrolides, cyclosporine, antipyrin, cholestyramine, gemfibrosil, warfarin),

• Malabsorption syndrome (over the first 48 hours).