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

Phase 3

Terminated

• Conditions: Ventilator Associated Pneumonia
• Interventions: Drug: Placebo; Drug: povidone iodine

• Registration Number: NCT00950027
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-04
• Last Update Posted: 2012-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 179

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
povidone iodine	povidone iodine	Povidone iodine

Primary Outcome Measures

Name	Time	Method
Rate of ventilator associated pneumonia	30 days

Secondary Outcome Measures

Name	Time	Method
Length of mechanical ventilation	30 days
Other infections	30 days
Type of anesthetic agents received	30 days
Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae	30 days
Length of ICU and hospital stay	Hospital discharge
Oropharyngeal bacterial colonisation	30 days
Acute respiratory distress syndrome	30 days
Time to ventilator associated pneumoniae	30 days
Death	ICU, 1 months, 3 months
Treatments administered (antibiotics, sedatives, transfusion)	30 days
Rate of transfusion (red blood cells, platelets, plasma)	30 days
Rate of tracheostomy	30 days

Trial Locations

Locations (7)

CHU de Rouen; 🇫🇷 Rouen, France

Réanimation chirurgicale CHU Tours; 🇫🇷 Tours, France

CHG Vannes; 🇫🇷 Vannes, France

CHU Angers; 🇫🇷 Angers, France

Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes; 🇫🇷 Nantes, France

CHU de Poitiers; 🇫🇷 Poitiers, France

Surgical Intensive Care Unit - CHU de Rennes; 🇫🇷 Rennes, France