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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital
  More Information

No publications provided by Rennes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 24, 2014