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Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00610324
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : February 7, 2008
Information provided by:
King Edward Memorial Hospital

Brief Summary:
Oropharyngeal bacteria play an important role in the pathogenesis of nosocomial pneumonia in critically ill patients. Oral cleansing with chlorhexidine has been shown to decrease incidence of pneumonia in patients undergoing open heart surgery. Its role in critically ill general ICU patients is not yet proven. The present study proposes to study the effectiveness of twice-daily oral cleansing with 0.2% chlorhexidine solution on the incidence of nosocomial pneumonia in ICU patients admitted to a single intensive care unit of an Indian public hospital

Condition or disease Intervention/treatment Phase
Nosocomial Pneumonia Healthcare-Associated Pneumonia Aspiration Pneumonia Ventilator-Associated Pneumonia Drug: Chlorhexidine gluconate Drug: Potassium permanganate Phase 4

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients: an Open-Labelled Randomized Controlled Trial
Study Start Date : May 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Experimental: 1
Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
Drug: Chlorhexidine gluconate
Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate

Active Comparator: 2
Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate
Drug: Potassium permanganate
Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate

Primary Outcome Measures :
  1. Development of nosocomial pneumonia [ Time Frame: During hospital stay ]

Secondary Outcome Measures :
  1. In-hospital mortality [ Time Frame: During hospital stay ]
  2. Length of ICU stay (days) [ Time Frame: Till discharge from ICU or death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00610324

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Medical-Neuro Intensive Care Unit, K E M Hospital, Parel
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
King Edward Memorial Hospital
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Principal Investigator: Dilip R Karnad, MD,FACP,FRCP Professor of Medicine, K E M Hospital, Parel, Mumbai 400012, India
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Responsible Party: Dr Dilip Karnad, Professor of Medicine, K E M Hospital, Mumbai Identifier: NCT00610324    
Other Study ID Numbers: DRK-CHEX
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: February 7, 2008
Last Verified: January 2008
Keywords provided by King Edward Memorial Hospital:
oropharyngeal cleansing
oral decontamination
oropharyngeal bacterial flora
oropharyngeal colonization
critical illness
mechanical ventilation
tracheal intubation
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Healthcare-Associated Pneumonia
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents