A study comparing a suspension of Lactobacillus plantarum 299 with chlorhexidine for oral care in intubated mechanically ventilated patients in intensive care

Completed

Conditions: Growth of pathogenic bacteria in the oral cavity
Oral Health

Registration Number: ISRCTN00472141

Lead Sponsor: Probi AB (Sweden)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. 18 years or older
2. Critically ill patients anticipated to require mechanical ventilation for at least 24 hours

Exclusion Criteria

1. Diagnosed with pneumonia at admission
2. Fractures on the facial skeleton or the skull base
3. Known ulcers in the oral cavity
4. Carrier of HIV or Hepatitis
5. Moribund

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cultures from the oropharynx and tracheal secretions are taken at inclusion (day 1) and then on days 2, 3, 5, 7, 10, 14 and 21 or before extubation if this occurs on a non-culture day (The primary outcomes are validated for the part of the ICU stay during which the patient is intubated). The results of the cultures are used to assess the following: <br>1. To compare the number of cultures with pathogenic bacteria and fungi from oropharynx and tracheal secretions and the spectra of these microbiologic species<br>2. Recovery of Lactobacillus plantarum 299 in the treatment group as an indicator of aspiration

Secondary Outcome Measures

Name	Time	Method
The following will be assessed during the ICU stay during which the patient is intubated: <br>1. Sequential Organ Failure Assessment (SOFA) score and Lung Injury Severity Score (LISS) will be measured daily during the ICU stay <br>2. Incidence of ventilator associated pneumonia during the ICU stay<br>3. Validation of microbiological findings compared to the use of antibiotics, monitored during the ICU stay<br>4. Infectious parameters (C-Reactive Protein [CRP] and White Blood Cell counts [WBC]), monitored daily during the ICU stay <br><br>For the whole ICU period:<br>5. ICU mortality <br><br>For the post-extubation period:<br>6. In-hospital mortality<br> <br>Follow-up for survival will be carried out for 6 months from admission to the ICU.