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

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Treatments: Cadexomer iodine; Iodine; Povidone; Povidone-Iodine

Criteria

Inclusion Criteria:

• Adults > 18 years

• Closed head trauma with a Glasgow Coma Score <=8 or cerebral Hemorrhage with a Glasgow Coma Score of <=8

• Expected need mechanical ventilation for >=2 days

• Written informed consent from the patient's next-of-kin. If no relative is present at the time of inclusion, the patients will be included according to the emergency procedure

Exclusion Criteria:

• Impossibility to perform oropharyngeal decontamination within 12 h following the initial episode

• Facial injury with impossibility to perform the oropharyngeal decontamination

• Tetraplegia

• Known history of reaction to iodine

• Respiratory disease or pulmonary infiltrate(s) at inclusion

• Need for curative antibiotics

• Mercurial antiseptics treatment

• Pregnancy