Status:
COMPLETED
Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia
Lead Sponsor:
Creighton University
Conditions:
Pneumonia
Ventilator Associated Pneumonia
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
This study utilizes lactobacillus, or probiotics, delivered twice daily to the mouth and stomach, via feeding tube, in effort to determine whether the oral administration of a naturally occurring Lact...
Detailed Description
The long-term objective of this research is to determine the utility of altering the oral and gastric bacterial flora in mechanically ventilated patients in order to reduce intensive care unit (ICU)co...
Eligibility Criteria
Inclusion
- Admission to the medical, surgical, or cardiac ICU
- Age 19 years or greater (the age of majority in the state of Nebraska)
- Anticipated need for \>72 hours of endotracheal intubation
- Initial intubation during hospitalization
- Approval of the attending physician responsible for the patient's care
- Informed surrogate consent within 24 hours of intubation
Exclusion
- Pregnancy
- Pharmacologic immunosuppression (\>10mg prednisone daily or equivalent for at least 14 days)
- Native immunosuppression: 1)known HIV disease or AIDS, 2)history of malignancy, 3)multiple organ system failure
- History of prosthetic or bioprosthetic cardiac valve placement
- History of prosthetic vascular graft placement
- Cardiac trauma
- History of rheumatic fever, endocarditis, congenital cardia abnormality, or acquired cardia abnormality
- Gastroesophageal surgery or perforation associated with current admission
- Intestinal surgery or perforation associated with current admission
- Significant oropharyngeal mucosal injury
- Placement of a tracheostomy
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00613795
Start Date
August 1 2004
End Date
November 1 2009
Last Update
March 18 2010
Active Locations (1)
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1
Creighton University Medical Center
Omaha, Nebraska, United States, 68131