Clinical trial NCT00950027: Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2009-07-31
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility 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

Primary outcomes:
measure: Rate of ventilator associated pneumonia
timeFrame: 30 days
Secondary outcomes:
measure: Time to ventilator associated pneumoniae
timeFrame: 30 days
measure: Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae
timeFrame: 30 days
measure: Length of mechanical ventilation
timeFrame: 30 days
measure: Other infections
timeFrame: 30 days
measure: Acute respiratory distress syndrome
timeFrame: 30 days
measure: Treatments administered (antibiotics, sedatives, transfusion)
timeFrame: 30 days
measure: Length of ICU and hospital stay
timeFrame: Hospital discharge
measure: Death
timeFrame: ICU, 1 months, 3 months
measure: Oropharyngeal bacterial colonisation
timeFrame: 30 days
measure: Type of anesthetic agents received
timeFrame: 30 days
measure: Rate of tracheostomy
timeFrame: 30 days
measure: Rate of transfusion (red blood cells, platelets, plasma)
timeFrame: 30 days
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Nantes
country: France
facility: Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: Surgical Intensive Care Unit - CHU de Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Tours
country: France
facility: Réanimation chirurgicale CHU Tours
city: Vannes
country: France
facility: CHG Vannes
Study officials:
affiliation: Rennes University Hospital
name: Philippe Seguin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Bruno Laviolle, MD
role: STUDY_CHAIR
References:
citation: Seguin P, Laviolle B, Dahyot-Fizelier C, Dumont R, Veber B, Gergaud S, Asehnoune K, Mimoz O, Donnio PY, Bellissant E, Malledant Y; Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage Patients (SPIRIT) ICU Study Group; AtlanRea Group. Effect of oropharyngeal povidone-iodine preventive oral care on ventilator-associated pneumonia in severely brain-injured or cerebral hemorrhage patients: a multicenter, randomized controlled trial. Crit Care Med. 2014 Jan;42(1):1-8. doi: 10.1097/CCM.0b013e3182a2770f.