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

Ventilator-Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610324
• Other study ID #: DRK-CHEX
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2008
• Last updated: January 24, 2008
• Start date: May 2004
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: King Edward Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Healthcare-Associated Pneumonia
• Nosocomial Pneumonia
• Pneumonia
• Pneumonia, Aspiration
• Pneumonia, Ventilator-Associated
• Ventilator-Associated Pneumonia

Intervention

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

Locations

Country	Name	City	State
India	Medical-Neuro Intensive Care Unit, K E M Hospital, Parel	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Memorial Hospital

Country where clinical trial is conducted

India, 

References & Publications (4)

Abele-Horn M, Dauber A, Bauernfeind A, Russwurm W, Seyfarth-Metzger I, Gleich P, Ruckdeschel G. Decrease in nosocomial pneumonia in ventilated patients by selective oropharyngeal decontamination (SOD). Intensive Care Med. 1997 Feb;23(2):187-95. — View Citation

DeRiso AJ 2nd, Ladowski JS, Dillon TA, Justice JW, Peterson AC. Chlorhexidine gluconate 0.12% oral rinse reduces the incidence of total nosocomial respiratory infection and nonprophylactic systemic antibiotic use in patients undergoing heart surgery. Chest. 1996 Jun;109(6):1556-61. — View Citation

Fourrier F, Cau-Pottier E, Boutigny H, Roussel-Delvallez M, Jourdain M, Chopin C. Effects of dental plaque antiseptic decontamination on bacterial colonization and nosocomial infections in critically ill patients. Intensive Care Med. 2000 Sep;26(9):1239-47. — View Citation

Francis JR, Hunter B, Addy M. A comparison of three delivery methods of chlorhexidine in handicapped children. I. Effects on plaque, gingivitis, and toothstaining. J Periodontol. 1987 Jul;58(7):451-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of nosocomial pneumonia		During hospital stay	No
Secondary	In-hospital mortality		During hospital stay	No
Secondary	Length of ICU stay (days)		Till discharge from ICU or death	No