NCT00610324

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2008

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
Last Updated

February 7, 2008

Status Verified

January 1, 2008

Enrollment Period

3.4 years

First QC Date

January 16, 2008

Last Update Submit

January 24, 2008

Conditions

Nosocomial PneumoniaHealthcare-Associated PneumoniaAspiration PneumoniaVentilator-Associated Pneumonia

Keywords

oropharyngeal cleansingoral decontaminationoropharyngeal bacterial floraoropharyngeal colonizationcritical illnessmechanical ventilationtracheal intubationprophylaxis

Outcome Measures

Primary Outcomes (1)

  • Development of nosocomial pneumonia

    During hospital stay

Secondary Outcomes (2)

  • In-hospital mortality

    During hospital stay

  • Length of ICU stay (days)

    Till discharge from ICU or death

Study Arms (2)

1

EXPERIMENTAL

Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate

Drug: Chlorhexidine gluconate

2

ACTIVE COMPARATOR

Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate

Drug: Potassium permanganate

Interventions

Chlorhexidine gluconateDRUG

Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate

1
Potassium permanganateDRUG

Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate

2

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to the medical intensive care unit and are expected to stay in ICU for \> 48 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical-Neuro Intensive Care Unit, K E M Hospital, Parel

Mumbai, Maharashtra, 400012, India

Location

Related 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. doi: 10.1007/s001340050314.

    PMID: 9069004BACKGROUND

  • 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. doi: 10.1378/chest.109.6.1556.

    PMID: 8769511BACKGROUND

  • 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. doi: 10.1007/s001340000585.

    PMID: 11089748BACKGROUND

  • 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. doi: 10.1902/jop.1987.58.7.451.

    PMID: 2957488BACKGROUND

MeSH Terms

Conditions

Healthcare-Associated PneumoniaPneumonia, AspirationPneumonia, Ventilator-AssociatedCritical Illness

Interventions

chlorhexidine gluconatePotassium Permanganate

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Manganese CompoundsInorganic ChemicalsPotassium Compounds

Study Officials

  • Dilip R Karnad, MD,FACP,FRCP

    Professor of Medicine, K E M Hospital, Parel, Mumbai 400012, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2008

First Posted

February 7, 2008

Study Start

May 1, 2004

Primary Completion

October 1, 2007

Study Completion

December 1, 2007

Last Updated

February 7, 2008

Record last verified: 2008-01

Locations

IN(1)