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

This study has been completed.
Sponsor:
Information provided by:
King Edward Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00610324
First received: January 16, 2008
Last updated: January 24, 2008
Last verified: January 2008
  Purpose

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 Intervention Phase
Nosocomial Pneumonia
Healthcare-Associated Pneumonia
Aspiration Pneumonia
Ventilator-Associated Pneumonia
Drug: Chlorhexidine gluconate
Drug: Potassium permanganate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by King Edward Memorial Hospital:

Primary Outcome Measures:
  • Development of nosocomial pneumonia [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In-hospital mortality [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
  • Length of ICU stay (days) [ Time Frame: Till discharge from ICU or death ] [ Designated as safety issue: No ]

Enrollment: 512
Study Start Date: May 2004
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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%.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610324

Locations
India
Medical-Neuro Intensive Care Unit, K E M Hospital, Parel
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
King Edward Memorial Hospital
Investigators
Principal Investigator: Dilip R Karnad, MD,FACP,FRCP Professor of Medicine, K E M Hospital, Parel, Mumbai 400012, India
  More Information

Publications:
Responsible Party: Dr Dilip Karnad, Professor of Medicine, K E M Hospital, Mumbai
ClinicalTrials.gov Identifier: NCT00610324     History of Changes
Other Study ID Numbers: DRK-CHEX
Study First Received: January 16, 2008
Last Updated: January 24, 2008
Health Authority: India: Institutional Review Board

Keywords provided by King Edward Memorial Hospital:
oropharyngeal cleansing
oral decontamination
oropharyngeal bacterial flora
oropharyngeal colonization
critical illness
mechanical ventilation
tracheal intubation
prophylaxis

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Aspiration
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 April 16, 2014