Chlorhexidine vs Lactobacillus Plantarum for Oral Care in Intubated ICU Patients

NCT01105819 | Completed DMC

• 1 other identifier: PROHYG 1B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Pathogenic Bacteria in the Oropharynx; Ventilator-associated Pneumonia

Keywords

Probiotics; Lactobacillus plantarum 299; Ventilator-associated pneumonia VAP; Chlorhexidine; Tracheal secretions; Oropharyngeal secretions

Outcome Measures

Primary Outcomes (2)

• 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

  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

  During study time in connection with the care in the ICU until invasive mechanical ventilation is terminated

Secondary Outcomes (7)

• SOFA score and Influence on lung function measured as Lung Injury Severity Score

  From admission to the ICU til discharge from the ICU

• Difference in emerge of Ventilator Associated Pneumonia

  During ICU stay

• Validation of micobiological findings compared to the use of antibiotics

  ICU stay + 48 hours

• C-reactive protein and white blood cell counts

  From admission to the ICU til discharge from the ICU

• Evaluation of microbiological cultures taken on clinical grounds

  ICU-stay + 48 hours

Study Arms (2)

Standard oral care with chlorhexidine

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

Procedure: Chlorhexidine for standard oral care

Lactobacillus plantarum 299

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

Procedure: Lactobacillus plantarum 299 for oral care

Interventions

Lactobacillus plantarum 299 for oral care PROCEDURE

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

Chlorhexidine for standard oral care PROCEDURE

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

Standard oral care with chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Critically ill patients anticipated to require mechanical ventilation for at least 24 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• County Council of Halland, Sweden: collaborator
• Probi AB: collaborator

Study Sites (3)

Intensive Care Unit, Halmstad Central Hospital

Halmstad, SE 301 85, Sweden

Location

Intensive Care Unit, Kristianstad Central hospital

Kristianstad, SE 291 85, Sweden

Location

Intensive Care Unit, Lund University Hospital

Lund, SE 221 85, Sweden

Location

Related Publications (2)

• Klarin B, Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Crit Care. 2008;12(6):R136. doi: 10.1186/cc7109. Epub 2008 Nov 6.

  PMID: 18990201 RESULT

• Klarin B, Adolfsson A, Torstensson A, Larsson A. Can probiotics be an alternative to chlorhexidine for oral care in the mechanically ventilated patient? A multicentre, prospective, randomised controlled open trial. Crit Care. 2018 Oct 28;22(1):272. doi: 10.1186/s13054-018-2209-4.

  PMID: 30368249 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD, PhD

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 19, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

SE (3)