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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00950027
First received: July 30, 2009
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Ventilator Associated Pneumonia
 Drug: povidone iodine
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Rate of ventilator associated pneumonia [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to ventilator associated pneumoniae [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Length of mechanical ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Other infections [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Acute respiratory distress syndrome [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Treatments administered (antibiotics, sedatives, transfusion) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of ICU and hospital stay [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • Death [ Time Frame: ICU, 1 months, 3 months ] [ Designated as safety issue: Yes ]
  • Oropharyngeal bacterial colonisation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Type of anesthetic agents received [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Rate of tracheostomy [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Rate of transfusion (red blood cells, platelets, plasma) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 179
Study Start Date: April 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: povidone iodine
Povidone iodine
 Drug: povidone iodine
oropharyngeal decontamination every 4 hours
Placebo Comparator: placebo Drug: Placebo
oropharyngeal decontamination every 4 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950027

Locations
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, France
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Philippe Seguin, MD, PhD CHU de Rennes
Study Chair: Bruno Laviolle, MD CHU de Rennes
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00950027     History of Changes
Other Study ID Numbers: EudraCT 2006-006353-27, AFSSAPS A70642-35, Sponsor PHRC/06-05 SPIRIT ICU
Study First Received: July 30, 2009
Last Updated: July 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Craniocerebral Trauma
Hemorrhage
Pneumonia
Pneumonia, Ventilator-Associated
Cerebral Hemorrhage
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
 Lung Injury
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Povidone
Iodine
Cadexomer iodine
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013