Official Title: “Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients: an Open-Labelled Randomized Controlled Trial”

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

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2007

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%.

Intervention(s) in this Clinical Trial

• Drug: Chlorhexidine gluconate
  • Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
• Drug: Potassium permanganate
  • Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
• Active Comparator: 2
  • Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate

Primary Measures

• Development of nosocomial pneumonia
  • Time Frame: During hospital stay
    Safety Issue?: No

Secondary Measures

• In-hospital mortality
  • Time Frame: During hospital stay
    Safety Issue?: No
• Length of ICU stay (days)
  • Time Frame: Till discharge from ICU or death
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: King Edward Memorial Hospital

Overall Clinical Trial Officials and Contacts

Dilip R Karnad, MD,FACP,FRCP Principal Investigator Professor of Medicine, K E M Hospital, Parel, Mumbai 400012, India  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00610324

Study ID Number: DRK-CHEX

ClinicalTrials.gov Identifier: NCT00610324

Health Authority: India: Institutional Review Board