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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
Sponsor:
Information provided by:
King Edward Memorial Hospital

Tracking Information
First Submitted Date  ICMJE January 16, 2008
First Posted Date  ICMJE February 7, 2008
Last Update Posted Date February 7, 2008
Study Start Date  ICMJE May 2004
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2008)
Development of nosocomial pneumonia [ Time Frame: During hospital stay ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2008)
  • In-hospital mortality [ Time Frame: During hospital stay ]
  • Length of ICU stay (days) [ Time Frame: Till discharge from ICU or death ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients
Official Title  ICMJE Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients: an Open-Labelled Randomized Controlled Trial
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Nosocomial Pneumonia
  • Healthcare-Associated Pneumonia
  • Aspiration Pneumonia
  • Ventilator-Associated Pneumonia
Intervention  ICMJE
  • Drug: Chlorhexidine gluconate
    Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
  • Drug: Potassium permanganate
    Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate
Study Arms  ICMJE
  • Experimental: 1
    Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
    Intervention: Drug: Chlorhexidine gluconate
  • Active Comparator: 2
    Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate
    Intervention: Drug: Potassium permanganate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2008)
512
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00610324
Other Study ID Numbers  ICMJE DRK-CHEX
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Dilip Karnad, Professor of Medicine, K E M Hospital, Mumbai
Study Sponsor  ICMJE King Edward Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dilip R Karnad, MD,FACP,FRCP Professor of Medicine, K E M Hospital, Parel, Mumbai 400012, India
PRS Account King Edward Memorial Hospital
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP