Status:
TERMINATED
Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit
Lead Sponsor:
Rennes University Hospital
Conditions:
Ventilator Associated Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 rep...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00950027
Start Date
April 1 2008
End Date
September 1 2011
Last Update
July 6 2012
Active Locations (7)
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1
CHU Angers
Angers, France
2
Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes
Nantes, France
3
CHU de Poitiers
Poitiers, France
4
Surgical Intensive Care Unit - CHU de Rennes
Rennes, France