Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit (SPIRIT-ICU)

Rennes University Hospital

Status and phase

Terminated

Phase 3

Conditions

Ventilator Associated Pneumonia

Treatments

Drug: Placebo

Drug: povidone iodine

Study type

Interventional

Funder types

Other

Identifiers

NCT00950027

AFSSAPS A70642-35 (Other Identifier)

EudraCT 2006-006353-27

Sponsor PHRC/06-05 SPIRIT ICU (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

179 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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