Overview

This trial is active, not recruiting.

Conditions pathogenic bacteria in the oropharynx, ventilator-associated pneumonia
Treatments lactobacillus plantarum 299 for oral care, chlorhexidine for standard oral care
Sponsor Region Skane
Collaborator County Council of Halland, Sweden
Start date April 2010
End date December 2015
Trial size 100 participants
Trial identifier NCT01105819, PROHYG 1B

Summary

Critically ill patients often need ventilatory support through a plastic tube connected to a ventilator. Those patients have a altered microbiological flora in the mouth, oropharynx as well as throughout the intestine. Bacteria that can cause illness are often found in the oropharynx in such patients and measures are taken in order to reduce the risk of secondary infections by those bacteria. In all intensive care patients oral care is provided by the nursing staff aiming at a reduction of the pathogenic species. This is done by a variety measures.

Chlorhexidine (CHX) is an antisepticum with a capability to reduce bacterial counts in the mouth and oropharynx and has been shown to be of value also for intubated patients. It is used frequently throughout the world.

Ventilator-associated pneumonia (VAP) is a costly rather frequent complication to intensive care and mechanical ventilation and is usually caused by aspiration of infected secretions from the oropharynx. CHX has in some studies been shown to reduce the frequency of VAP.

The probiotic bacterium Lactobacillus plantarum 299 has the ability to adhere to the mucosa throughout the gastro-intestinal tract including the mouth and in our pilot study we found that L plantarum had better ability to reduce colonisation with enteric bacteria in the oropharynx than CHX had. Figures not statistical significant so this present study is aiming to get a larger amount of data.

The procedure was found to be safe Hypothesis: Lactobacillus plantarum is better than CHX for the reduction of pathogenic bacteria in the oropharynx in intubated mechanically ventilated patients and consequently has a better potential to reduce the frequency of VAP

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Other)
The control group will receive a standard oral care. This includes suction of secretions, brushing of teeth cleansing of the oral cavity with swabs soaked with a chlorhexidine solution. This procedure is performed twice a day. In between, suction whenever needed and cleansing with swabs soaked with carbonated bottled water is performed
chlorhexidine for standard oral care
A The control group will receive the standard oral care of the department (general ICU, Lund University Hospital). This includes suction of secretions, brushing of teeth cleansing of the oral cavity with swabs soaked with a chlorhexidine solution. This procedure is performed twice a day. In between, suction whenever needed and cleansing with swabs soaked with carbonated bottled water is performed 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
(Active Comparator)
The study group will be attended in the same manor but the swabs used for cleansing are soaked with carbonated water directly from freshly opened bottles. As the final part of the procedure oral mucosal surfaces are pencilled with a suspension of the probiotic bacterium Lactobacillus plantarum 299 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
lactobacillus plantarum 299 for oral care
The study group will be attended in the same manor but the swabs used for cleansing are soaked with carbonated water directly from freshly opened bottles. As the final part of the procedure oral mucosal surfaces are pencilled with a suspension of the probiotic bacterium Lactobacillus plantarum 299 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

Primary Outcomes

Measure
To compare the number and frequency of cultures with pathogenic bacteria and fungi from the oropharynx and tracheal secretions and the spectra of these microbiological species
time frame: During study time in connection with the care in the ICU until invasive mechanical ventilation is terminated
Recovery of Lactobacillus plantarum 299 in tracheal secretions in the active treatment group as an indicator of aspiration
time frame: During study time in connection with the care in the ICU until invasive mechanical ventilation is terminated

Secondary Outcomes

Measure
SOFA score and Influence on lung function measured as Lung Injury Severity Score
time frame: From admission to the ICU til discharge from the ICU
Difference in emerge of Ventilator Associated Pneumonia
time frame: During ICU stay
Validation of micobiological findings compared to the use of antibiotics
time frame: ICU stay + 48 hours
C-reactive protein and white blood cell counts
time frame: From admission to the ICU til discharge from the ICU
Evaluation of microbiological cultures taken on clinical grounds
time frame: ICU-stay + 48 hours
28 day mortality
time frame: 28 days after ICU admission
6 months mortality
time frame: 6 months after ICU admission

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years or older - Critically ill patients anticipated to require mechanical ventilation for at least 24 hours Exclusion Criteria: - Pneumonia as admission diagnosis, - Fractures on the facial skeleton or the skull base; - Known ulcers in the oral cavity, the oropharynx, or the esophagus - Known immune difficency - Carrier of HIV or Hepatitis - Patient being moribund

Additional Information

Official title A Study Comparing a Suspension of Lactobacillus Plantarum 299 With Chlorhexidine for Oral Care in Intubated Mechanically Ventilated Patients in Intensive Care
Description This study is an expansion of a pilot study performed at the ICU Lund University Hospital, Sweden where 50 patients were included (ISRCTN00472141). Results have been published in Critical Care 2008, 12:R136 The protocol is the same and in this second phase we intend to include 100 patients and results will be summed up. Three centres are engaged. The results from the pilot study is encouraging and we are aiming at getting statistical significance in the differences in pathogenic findings in the cultures from oropharynx and also better a better basis for the calculation of the number of patients needed to get sufficient power to study difference in VAP frequency.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Region Skane.