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

NCT ID: NCT00950027

Last Updated: 2012-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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povidone iodine

Povidone iodine

Group Type EXPERIMENTAL

povidone iodine

Intervention Type DRUG

oropharyngeal decontamination every 4 hours

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oropharyngeal decontamination every 4 hours

Interventions

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povidone iodine

oropharyngeal decontamination every 4 hours

Intervention Type DRUG

Placebo

oropharyngeal decontamination every 4 hours

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Seguin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Bruno Laviolle, MD

Role: STUDY_CHAIR

Rennes University Hospital

Locations

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CHU Angers

Angers, , France

Site Status

Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes

Nantes, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

Surgical Intensive Care Unit - CHU de Rennes

Rennes, , France

Site Status

CHU de Rouen

Rouen, , France

Site Status

Réanimation chirurgicale CHU Tours

Tours, , France

Site Status

CHG Vannes

Vannes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 24105456 (View on PubMed)

Other Identifiers

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AFSSAPS A70642-35

Identifier Type: OTHER

Identifier Source: secondary_id

Sponsor PHRC/06-05 SPIRIT ICU

Identifier Type: OTHER

Identifier Source: secondary_id

EudraCT 2006-006353-27

Identifier Type: -

Identifier Source: org_study_id