Chlorhexidine vs Lactobacillus Plantarum for Oral Care in Intubated ICU Patients
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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 |
- 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 ]
- 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: | April 2014 |
| Estimated Primary Completion Date: | October 2013 (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 |
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| 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 |
| Sweden | |
| Intensive Care Unit, Halmstad Central Hospital | Recruiting |
| Halmstad, Sweden, SE 301 85 | |
| Contact: Matts Juhlin-Dannfelt, MD, Dir ICU +46 350 131279 matts.juhlin-dannfelt@lthalland.se | |
| Contact: Carina Månsson, RN +46 350 131279 carina.mansson@lthalland.se | |
| Principal Investigator: Matts Juhlin-Dannfelt, MD, | |
| Intensive Care Unit, Kristianstad Central hospital | Recruiting |
| Kristianstad, Sweden, SE 291 85 | |
| Contact: Keld Brodersen, MD +46 44 3092200 Keld.N.Brodersen@skane.se | |
| Contact: Marika Hall, RN +46 443091149 Marika.Hall@skane.se | |
| Principal Investigator: Keld Brodersen, MD | |
| 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 | |
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: | November 6, 2012 |
| 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 Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection Infection Ventilator-Induced Lung Injury Lung Injury |
Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Disinfectants Dermatologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013