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

NCT00950027 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2012-07-06

No results posted yet for this study

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.

Conditions

  • Ventilator Associated Pneumonia

Interventions

DRUG

povidone iodine

oropharyngeal decontamination every 4 hours

DRUG

Placebo

oropharyngeal decontamination every 4 hours

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Philippe Seguin, MD, PhD · Rennes University Hospital

  • Bruno Laviolle, MD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00950027 on ClinicalTrials.gov