Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256074
Status:
TERMINATED
Last Update Posted:
2017-04-12
First Post:
2005-11-17
Brief Title:
The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
Official Title:
The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision was made to terminate the project due to slower than anticipated recruitment and many of the investigators no longer being available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the impact of different feeding solutions on patients with breathing difficulty being supported by a breathing machine
The aim of the study is to determine if high fat-low carbohydrate feeding reduces the carbon dioxide production in patients with respiratory failure
The aim of the study is to determine if high fat-low carbohydrate feeding reduces the carbon dioxide production in patients with respiratory failure
Detailed Description:
Patients who agree to participate in the study and fulfil the inclusion criteria will be randomised to one of two treatment groups
1 Standard therapy group Will receive high carbohydrate low fat enteral feeding 167 protein 30 fat and 533 carbohydrate The target rate is determined by the treating physician and dietician for a minimum of 5 days following randomisation
2 Alternative therapy group will receive high-fat low carbohydrate enteral feeding 167 protein 552 fat and 281 carbohydrates At a target rate determined by the treating physician and dietician for a maximum of 5 days following randomisation
All patients will receive enteral feeding by continuous flow for 24 hours a day The decision to commence or cease enteral feeding will remain with the treating physician
The measurement of VO2 VCO2 resting energy expenditure and respiratory quotient wil be made on all participants 12 hourly for a maximum of 5 days using the direct calorimeter The indirect calorimeter is connected to the expiratory outlet of the ventilator collecting and analyzing gas that is normally discharged in to the atmosphere
The hypothesis of the study is that the use of high- fat low-carbohydrate enteral feed significantly reduces the carbon dioxide production and the respiratory quotient in critically ill mechanically ventilated patients with respiratory failure Compared to standard high-carbohydrate low-fat enteral feed
1 Standard therapy group Will receive high carbohydrate low fat enteral feeding 167 protein 30 fat and 533 carbohydrate The target rate is determined by the treating physician and dietician for a minimum of 5 days following randomisation
2 Alternative therapy group will receive high-fat low carbohydrate enteral feeding 167 protein 552 fat and 281 carbohydrates At a target rate determined by the treating physician and dietician for a maximum of 5 days following randomisation
All patients will receive enteral feeding by continuous flow for 24 hours a day The decision to commence or cease enteral feeding will remain with the treating physician
The measurement of VO2 VCO2 resting energy expenditure and respiratory quotient wil be made on all participants 12 hourly for a maximum of 5 days using the direct calorimeter The indirect calorimeter is connected to the expiratory outlet of the ventilator collecting and analyzing gas that is normally discharged in to the atmosphere
The hypothesis of the study is that the use of high- fat low-carbohydrate enteral feed significantly reduces the carbon dioxide production and the respiratory quotient in critically ill mechanically ventilated patients with respiratory failure Compared to standard high-carbohydrate low-fat enteral feed
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