Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122408
Status:
TERMINATED
Last Update Posted:
2010-09-24
First Post:
2005-07-19
Brief Title:
Probiotic Enteral Administration in Mechanically Ventilated Patients
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Effect of Enterally Administered Probiotics in Mechanically Ventilated Patients Double-Blind Prospective Randomized Study Versus Placebo
Status:
TERMINATED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to assess the effects of a daily enteral supplementation with probiotics within a population of critically ill mechanically ventilated patients Especially the effects of probiotics on mortality rate in intensive care medicine will be analysed
Detailed Description:
In a critically ill patient the gut integrity is rapidly compromised either by the treatments used such as catecholamine or antibiotics or by the disease itself This gut alteration favours the adhesion andor internalisation of bacteria by intestine cells which lead to the production of large amounts of cytokines that rapidly reach the blood compartment inducing neutrophils activation and then organ damage Moreover the imbalance in the normal intestinal flora demonstrated as early as 24 hours after ICU admission is one of the mechanisms involved in the development of ventilator associated pneumonia VAP VAP is the leading cause of ICU-acquired infection and is responsible for prolonged ICU stay increased mortality and costs Probiotics and especially Lactobacillus Rhamnosus GG LGG have been demonstrated to possess beneficial effects in terms of intestine flora imbalance and immune response
Objective To study the effects of a probiotic mixture containing LGG enteral administration on the survival and the incidence of VAP in mechanically ventilated patients
Patients and Methods Prospective randomized double-blind placebo-controlled study After randomization 740 intubated patients with a predictive length of mechanical support of more than 48 hours will enterally receive either 1010 cfu of probiotic Ergyphilus Nutergia France or a identical placebo daily until withdrawal of mechanical support The main endpoint is the mortality rate in ICU Secondary endpoints include hospital length of stay and mortality rate VAP incidence and the number of days free from antibiotics Length of the study 24 months
Perspectives The objective is to demonstrate a survival advantage due to LGG administration along with a reduction of VAP episodes and antibiotic use
Objective To study the effects of a probiotic mixture containing LGG enteral administration on the survival and the incidence of VAP in mechanically ventilated patients
Patients and Methods Prospective randomized double-blind placebo-controlled study After randomization 740 intubated patients with a predictive length of mechanical support of more than 48 hours will enterally receive either 1010 cfu of probiotic Ergyphilus Nutergia France or a identical placebo daily until withdrawal of mechanical support The main endpoint is the mortality rate in ICU Secondary endpoints include hospital length of stay and mortality rate VAP incidence and the number of days free from antibiotics Length of the study 24 months
Perspectives The objective is to demonstrate a survival advantage due to LGG administration along with a reduction of VAP episodes and antibiotic use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None