Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit
Information source: Rennes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ventilator Associated Pneumonia
Intervention: povidone iodine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Rennes University Hospital Official(s) and/or principal investigator(s): Philippe Seguin, MD, PhD, Principal Investigator, Affiliation: Rennes University Hospital Bruno Laviolle, MD, Study Chair, Affiliation: Rennes University Hospital
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Rate of ventilator associated pneumonia
Secondary outcome: Time to ventilator associated pneumoniaeRate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae Length of mechanical ventilation Other infections Acute respiratory distress syndrome Treatments administered (antibiotics, sedatives, transfusion) Length of ICU and hospital stay Death Oropharyngeal bacterial colonisation Type of anesthetic agents received Rate of tracheostomy Rate of transfusion (red blood cells, platelets, plasma)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
CHU Angers, Angers, France
RĂ©animation chirurgical Hopital Hotel Dieu-CHU de Nantes, Nantes, France
CHU de Poitiers, Poitiers, France
Surgical Intensive Care Unit - CHU de Rennes, Rennes, France
CHU de Rouen, Rouen, France
RĂ©animation chirurgicale CHU Tours, Tours, France
CHG Vannes, Vannes, France
Additional Information
Starting date: April 2008
Last updated: July 4, 2012
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