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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00950027
Recruitment Status : Terminated
First Posted : July 31, 2009
Last Update Posted : July 6, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Drug: povidone iodine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : April 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: povidone iodine
Povidone iodine
Drug: povidone iodine
oropharyngeal decontamination every 4 hours

Placebo Comparator: placebo Drug: Placebo
oropharyngeal decontamination every 4 hours

Primary Outcome Measures :
  1. Rate of ventilator associated pneumonia [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Time to ventilator associated pneumoniae [ Time Frame: 30 days ]
  2. Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae [ Time Frame: 30 days ]
  3. Length of mechanical ventilation [ Time Frame: 30 days ]
  4. Other infections [ Time Frame: 30 days ]
  5. Acute respiratory distress syndrome [ Time Frame: 30 days ]
  6. Treatments administered (antibiotics, sedatives, transfusion) [ Time Frame: 30 days ]
  7. Length of ICU and hospital stay [ Time Frame: Hospital discharge ]
  8. Death [ Time Frame: ICU, 1 months, 3 months ]
  9. Oropharyngeal bacterial colonisation [ Time Frame: 30 days ]
  10. Type of anesthetic agents received [ Time Frame: 30 days ]
  11. Rate of tracheostomy [ Time Frame: 30 days ]
  12. Rate of transfusion (red blood cells, platelets, plasma) [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00950027

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, France
Sponsors and Collaborators
Rennes University Hospital
Principal Investigator: Philippe Seguin, MD, PhD Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rennes University Hospital Identifier: NCT00950027     History of Changes
Other Study ID Numbers: EudraCT 2006-006353-27
AFSSAPS A70642-35 ( Other Identifier: AFSSAPS: French Health Products Safety Agency )
Sponsor PHRC/06-05 SPIRIT ICU ( Other Identifier: Rennes University Hospital )
First Posted: July 31, 2009    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Craniocerebral Trauma
Cerebral Hemorrhage
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements