- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00610324
Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients
Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients: an Open-Labelled Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nosocomial pneumonia is common in intensive care units (ICU) patients and is associated with increase in mortality rates by 24% to 76% in various studies. Interventions that effectively prevent nosocomial pneumonia are strategically important in order to reduce morbidity, mortality and healthcare costs. Colonization of the pharynx has been implicated as the reservoirs for pathogens causing nosocomial pneumonia and interventions like selective digestive decontamination have been tried to control this source of infection. Recently, colonization of the dental plaque by aerobic organisms with subsequent aspiration into the lower respiratory tract has received attention. Previous smaller studies using antiseptic agents to sterilize dental plaques in patients at risk of pneumonia have shown conflicting results. The present study aims to determine whether twice daily oral cleansing with 0.2% chlorhexidine reduces the incidence of nosocomial pneumonia in patients staying in the ICU for >48 hours.
After obtaining informed consent, subjects would be randomized to treatment with either 0.2% chlorhexidine gluconate (CHG) solution or 0.01% potassium permanganate solution (PP) (Control Group), as per the protocol approved by the Institutional Ethics Committee. At baseline, the parameters which would be noted are: age, sex, surgical or non-surgical status, immunosuppression, chronic ailments, smoking and alcohol consumption, Glasgow coma scale score (GCS), laboratory parameters and blood gas analysis. All subjects would be followed up daily and the GCS, presence of nasogastric tube (feeds), endotracheal tube, tracheostomy, ventilator, central venous and urinary catheterization, anti-stress ulcer prophylaxis and prior antibiotic use will be noted. Presence or absence of nosocomial pneumonia would also be noted daily. Lower respiratory secretions would be obtained by the protected non-bronchoscopic mini-BAL technique in order to identify the causative organisms. All the subjects will be followed up daily until discharge from the ICU or death.
Primary outcome variable was the development of nosocomial pneumonia during the ICU stay. Secondary outcome variables were hospital mortality, length of ICU stay.
A total of 506 patients will have to be studied (approximately 253 patients in each treatment group). This study will have a statistical power of 75% to detect a 50% reduction in the incidence of nosocomial pneumonia in the intervention group with a 95% level of confidence assuming that incidence of pneumonia in the control group is 16%.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
Maharashtra
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Mumbai, Maharashtra, India, 400012
- Medical-Neuro Intensive Care Unit, K E M Hospital, Parel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients admitted to the medical intensive care unit and are expected to stay in ICU for > 48 hours
Exclusion Criteria:
- Pregnant women
- Patients with nosocomial pneumonia at time of ICU admission
- Patients with community-acquired pneumonia at time of ICU admission
- Patients in whom oropharyngeal cleansing is contra-indicated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
|
Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
|
ACTIVE_COMPARATOR: 2
Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate
|
Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of nosocomial pneumonia
Time Frame: During hospital stay
|
During hospital stay
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In-hospital mortality
Time Frame: During hospital stay
|
During hospital stay
|
Length of ICU stay (days)
Time Frame: Till discharge from ICU or death
|
Till discharge from ICU or death
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilip R Karnad, MD,FACP,FRCP, Professor of Medicine, K E M Hospital, Parel, Mumbai 400012, India
Publications and helpful links
General Publications
- Abele-Horn M, Dauber A, Bauernfeind A, Russwurm W, Seyfarth-Metzger I, Gleich P, Ruckdeschel G. Decrease in nosocomial pneumonia in ventilated patients by selective oropharyngeal decontamination (SOD). Intensive Care Med. 1997 Feb;23(2):187-95. doi: 10.1007/s001340050314.
- DeRiso AJ 2nd, Ladowski JS, Dillon TA, Justice JW, Peterson AC. Chlorhexidine gluconate 0.12% oral rinse reduces the incidence of total nosocomial respiratory infection and nonprophylactic systemic antibiotic use in patients undergoing heart surgery. Chest. 1996 Jun;109(6):1556-61. doi: 10.1378/chest.109.6.1556.
- Fourrier F, Cau-Pottier E, Boutigny H, Roussel-Delvallez M, Jourdain M, Chopin C. Effects of dental plaque antiseptic decontamination on bacterial colonization and nosocomial infections in critically ill patients. Intensive Care Med. 2000 Sep;26(9):1239-47. doi: 10.1007/s001340000585.
- Francis JR, Hunter B, Addy M. A comparison of three delivery methods of chlorhexidine in handicapped children. I. Effects on plaque, gingivitis, and toothstaining. J Periodontol. 1987 Jul;58(7):451-5. doi: 10.1902/jop.1987.58.7.451.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Cross Infection
- Iatrogenic Disease
- Healthcare-Associated Pneumonia
- Pneumonia
- Pneumonia, Aspiration
- Pneumonia, Ventilator-Associated
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Dermatologic Agents
- Disinfectants
- Chlorhexidine
- Chlorhexidine gluconate
Other Study ID Numbers
- DRK-CHEX
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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