Chlorhexidine vs Lactobacillus Plantarum for Oral Care in Intubated ICU Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Region Skane
Sponsor:
Collaborators:
County Council of Halland, Sweden
Probi AB
Information provided by (Responsible Party):
Bengt Klarin, Region Skane
ClinicalTrials.gov Identifier:
NCT01105819
First received: April 9, 2010
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention
Pathogenic Bacteria in the Oropharynx
Ventilator-associated Pneumonia
Procedure: Lactobacillus plantarum 299 for oral care
Procedure: Chlorhexidine for standard oral care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study Comparing a Suspension of Lactobacillus Plantarum 299 With Chlorhexidine for Oral Care in Intubated Mechanically Ventilated Patients in Intensive Care

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Difference in emerge of Ventilator Associated Pneumonia [ Time Frame: During ICU stay ] [ Designated as safety issue: Yes ]
  • Validation of micobiological findings compared to the use of antibiotics [ Time Frame: ICU stay + 48 hours ] [ Designated as safety issue: Yes ]
  • C-reactive protein and white blood cell counts [ Time Frame: From admission to the ICU til discharge from the ICU ] [ Designated as safety issue: Yes ]
  • Evaluation of microbiological cultures taken on clinical grounds [ Time Frame: ICU-stay + 48 hours ] [ Designated as safety issue: Yes ]

    We want to examine the possible influence of the added probioticum on the frequence of positive cultures from other sites than those taken per protocol.

    Samples taken during ICU-stay and 48 hours after discharge from the ICU will be examened The type of species in positive cultures are also of interest. Blood cultures may act as indicator of vascular spread of the studied bacterium.

    According to the protocol samples for blood cultures are not taken


  • 28 day mortality [ Time Frame: 28 days after ICU admission ] [ Designated as safety issue: Yes ]
  • 6 months mortality [ Time Frame: 6 months after ICU admission ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard oral care with chlorhexidine
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
Procedure: 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: Lactobacillus plantarum 299
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
Procedure: 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01105819

Contacts
Contact: Bengt Klarin, B Sci, MD, PhD +46 46 171941 Bengt.Klarin@med.lu.se
Contact: Anne Adolfsson, RN +46 46 173805 anne.adolfsson@skane.se

Locations
Sweden
Intensive Care Unit, Halmstad Central Hospital Completed
Halmstad, Sweden, SE 301 85
Intensive Care Unit, Kristianstad Central hospital Completed
Kristianstad, Sweden, SE 291 85
Intensive Care Unit, Lund University Hospital Recruiting
Lund, Sweden, SE 221 85
Contact: Bengt Klarin, MD, PhD    +46 46 171941    Bengt.Klarin@med.lu.se   
Contact: Anne Adolfsson, RN    +46 46 173805    anne.adolfsson@skane.se   
Principal Investigator: Bengt Klarin, MD, PhD         
Sponsors and Collaborators
Region Skane
County Council of Halland, Sweden
Probi AB
  More Information

Publications:
Responsible Party: Bengt Klarin, Consultant, MD, PhD, Region Skane
ClinicalTrials.gov Identifier: NCT01105819     History of Changes
Other Study ID Numbers: PROHYG 1B
Study First Received: April 9, 2010
Last Updated: October 21, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Probiotics
Lactobacillus plantarum 299
Ventilator-associated pneumonia VAP
Chlorhexidine
Tracheal secretions
Oropharyngeal secretions

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Cross Infection
Infection
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Respiratory Tract Infections
Ventilator-Induced Lung Injury
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014