NCT00950027

Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit

Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.

Conditions

• Ventilator Associated Pneumonia

Interventions

Type	Name	Description
DRUG	povidone iodine	oropharyngeal decontamination every 4 hours
DRUG	Placebo	oropharyngeal decontamination every 4 hours

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-07-31
• Last updated: 2012-07-06

Locations

7 sites across 1 country: France