Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients
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ClinicalTrials.gov Identifier: NCT00610324 |
Recruitment Status :
Completed
First Posted : February 7, 2008
Last Update Posted : February 7, 2008
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Condition or disease | Intervention/treatment | Phase |
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Nosocomial Pneumonia Healthcare-Associated Pneumonia Aspiration Pneumonia Ventilator-Associated Pneumonia | Drug: Chlorhexidine gluconate Drug: Potassium permanganate | Phase 4 |
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 : | 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 |
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Experimental: 1
Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
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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 |
- Development of nosocomial pneumonia [ Time Frame: During hospital stay ]
- In-hospital mortality [ Time Frame: During hospital stay ]
- Length of ICU stay (days) [ Time Frame: Till discharge from ICU or death ]

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00610324
India | |
Medical-Neuro Intensive Care Unit, K E M Hospital, Parel | |
Mumbai, Maharashtra, India, 400012 |
Principal Investigator: | Dilip R Karnad, MD,FACP,FRCP | Professor of Medicine, K E M Hospital, Parel, Mumbai 400012, India |
Responsible Party: | Dr Dilip Karnad, Professor of Medicine, K E M Hospital, Mumbai |
ClinicalTrials.gov 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 |
oropharyngeal cleansing oral decontamination oropharyngeal bacterial flora oropharyngeal colonization |
critical illness mechanical ventilation tracheal intubation prophylaxis |
Pneumonia, Ventilator-Associated Healthcare-Associated Pneumonia Pneumonia Pneumonia, Aspiration Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection Infection |
Iatrogenic Disease Disease Attributes Pathologic Processes Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Dermatologic Agents |