The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation
Recruitment status was Recruiting
Tracking Information | |||||||||
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First Received Date ICMJE | November 17, 2005 | ||||||||
Last Updated Date | February 3, 2009 | ||||||||
Start Date ICMJE | June 2004 | ||||||||
Primary Completion Date | |||||||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
Original Primary Outcome Measures ICMJE |
To determine if high-fat low-carbohydrate enteral feeding reduces the carbon dioxide production and the respiratory quotient in patients with respiratory failure. | ||||||||
Change History | Complete list of historical versions of study NCT00256074 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation | ||||||||
Official Title ICMJE | The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation | ||||||||
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. |
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Detailed Description | Patients who agree to participate in the study and fulfil the inclusion criteria, will be randomised to one of two treatment groups.
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | |||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Critically Ill Patients Who Require Mechanical Ventilation. | ||||||||
Intervention ICMJE | Procedure: Enteral feeding formula | ||||||||
Study Arm (s) | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 30 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Australia | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00256074 | ||||||||
Other Study ID Numbers ICMJE | 2003.263 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | |||||||||
Study Sponsor ICMJE | Melbourne Health | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | Melbourne Health | ||||||||
Verification Date | February 2009 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |