The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation
Recruitment status was Recruiting
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.
Critically Ill Patients Who Require Mechanical Ventilation.
Procedure: Enteral feeding formula
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation|
- To determine if high-fat low-carbohydrate enteral feeding reduces the carbon dioxide production and the respiratory quotient in patients with respiratory failure. [ Time Frame: patients will be followed until death or hospital discharge ]
- 1. If high-fat, low-carbohydrate enteral feeding reduces carbon dioxide production, dead space ventilation the number of days spent on mechanical ventilation,or the length of ICU stay, hospital length of stay or mortality. [ Time Frame: patients will be followed until death or hospital discharge ]
|Study Start Date:||June 2004|
Patients who agree to participate in the study and fulfil the inclusion criteria, will be randomised to one of two treatment groups.
- Standard therapy group. Will receive high carbohydrate, low fat enteral feeding, (16.7% protein, 30% fat and 53.3% carbohydrate). The target rate is determined by the treating physician and dietician, for a minimum of 5 days following randomisation.
- Alternative therapy group will receive high-fat, low carbohydrate enteral feeding, (16.7% protein, 55.2% fat and 28.1% 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256074
|Contact: Megan Robertson, MBBS||+ 61 3 firstname.lastname@example.org|
|Contact: Deborah Barge||+ 61 3 email@example.com|
|Intensive Care Unit, The Royal Melbourne Hospital,||Recruiting|
|Parkville,, Victoria, Australia, 3050|
|Contact: Megan Robertson, MBBS +61 3 93427441 firstname.lastname@example.org|
|Contact: Deborah Barge +61 3 93427710 email@example.com|
|Principal Investigator: Megan Robertson, MBBS|
|Principal Investigator:||Megan Robertson, MBBS||Melbourne Health|