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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 pneumoniae

Rate 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

Page last updated: August 23, 2015

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