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

Ventilator Associated Pneumonia Clinical Trial

— SPIRIT-ICU  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00950027
• Other study ID #: EudraCT 2006-006353-27
• Secondary ID: AFSSAPS A70642-3
• Status: Terminated
• Phase: Phase 3
• First received: July 30, 2009
• Last updated: July 4, 2012
• Start date: April 2008
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 179
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Drug:
• povidone iodine
oropharyngeal decontamination every 4 hours
• Placebo
oropharyngeal decontamination every 4 hours

Locations

Country	Name	City	State
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	CHU de Rouen	Rouen
France	Réanimation chirurgicale CHU Tours	Tours
France	CHG Vannes	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ventilator associated pneumonia		30 days	Yes
Secondary	Time to ventilator associated pneumoniae		30 days	Yes
Secondary	Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae		30 days	Yes
Secondary	Length of mechanical ventilation		30 days	No
Secondary	Other infections		30 days	Yes
Secondary	Acute respiratory distress syndrome		30 days	Yes
Secondary	Treatments administered (antibiotics, sedatives, transfusion)		30 days	No
Secondary	Length of ICU and hospital stay		Hospital discharge	No
Secondary	Death		ICU, 1 months, 3 months	Yes
Secondary	Oropharyngeal bacterial colonisation		30 days	No
Secondary	Type of anesthetic agents received		30 days	No
Secondary	Rate of tracheostomy		30 days	No
Secondary	Rate of transfusion (red blood cells, platelets, plasma)		30 days	No