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

Primary Purpose

Ventilator Associated Pneumonia

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
povidone iodine
Placebo
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Angers
  • Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes
  • CHU de Poitiers
  • Surgical Intensive Care Unit - CHU de Rennes
  • CHU de Rouen
  • Réanimation chirurgicale CHU Tours
  • CHG Vannes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

povidone iodine

placebo

Arm Description

Povidone iodine

Outcomes

Primary Outcome Measures

Rate of ventilator associated pneumonia

Secondary Outcome Measures

Time to ventilator associated pneumoniae
Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae
Length of mechanical ventilation
Other infections
Acute respiratory distress syndrome
Treatments administered (antibiotics, sedatives, transfusion)
Length of ICU and hospital stay
Death
Oropharyngeal bacterial colonisation
Type of anesthetic agents received
Rate of tracheostomy
Rate of transfusion (red blood cells, platelets, plasma)

Full Information

First Posted
July 30, 2009
Last Updated
July 4, 2012
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00950027
Brief Title
Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit
Acronym
SPIRIT-ICU
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
povidone iodine
Arm Type
Experimental
Arm Description
Povidone iodine
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
povidone iodine
Intervention Description
oropharyngeal decontamination every 4 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oropharyngeal decontamination every 4 hours
Primary Outcome Measure Information:
Title
Rate of ventilator associated pneumonia
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time to ventilator associated pneumoniae
Time Frame
30 days
Title
Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae
Time Frame
30 days
Title
Length of mechanical ventilation
Time Frame
30 days
Title
Other infections
Time Frame
30 days
Title
Acute respiratory distress syndrome
Time Frame
30 days
Title
Treatments administered (antibiotics, sedatives, transfusion)
Time Frame
30 days
Title
Length of ICU and hospital stay
Time Frame
Hospital discharge
Title
Death
Time Frame
ICU, 1 months, 3 months
Title
Oropharyngeal bacterial colonisation
Time Frame
30 days
Title
Type of anesthetic agents received
Time Frame
30 days
Title
Rate of tracheostomy
Time Frame
30 days
Title
Rate of transfusion (red blood cells, platelets, plasma)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Seguin, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Laviolle, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes
City
Nantes
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Facility Name
Surgical Intensive Care Unit - CHU de Rennes
City
Rennes
Country
France
Facility Name
CHU de Rouen
City
Rouen
Country
France
Facility Name
Réanimation chirurgicale CHU Tours
City
Tours
Country
France
Facility Name
CHG Vannes
City
Vannes
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24105456
Citation
Seguin P, Laviolle B, Dahyot-Fizelier C, Dumont R, Veber B, Gergaud S, Asehnoune K, Mimoz O, Donnio PY, Bellissant E, Malledant Y; Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage Patients (SPIRIT) ICU Study Group; AtlanRea Group. Effect of oropharyngeal povidone-iodine preventive oral care on ventilator-associated pneumonia in severely brain-injured or cerebral hemorrhage patients: a multicenter, randomized controlled trial. Crit Care Med. 2014 Jan;42(1):1-8. doi: 10.1097/CCM.0b013e3182a2770f.
Results Reference
derived

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

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