The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Melbourne Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00256074
First received: November 17, 2005
Last updated: February 3, 2009
Last verified: February 2009

November 17, 2005
February 3, 2009
June 2004
 
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 ]
To determine if high-fat low-carbohydrate enteral feeding reduces the carbon dioxide production and the respiratory quotient in patients with respiratory failure.
Complete list of historical versions of study NCT00256074 on ClinicalTrials.gov Archive Site
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 ]
  • 1. If high-fat, low-carbohydrate enteral feeding reduces the number of days spent on mechanical ventilation or the length of ICU stay.
  • 2. To assess whether an excessive carbohydrate load increases CO2 production (VCO2), in patients with acute respiratory failure.
 
 
 
The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation
The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation

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.

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, (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.
  2. 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.

Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Critically Ill Patients Who Require Mechanical Ventilation.
Procedure: Enteral feeding formula
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
 
 

Inclusion Criteria:

  1. Adult patient, 18 years or older admitted with acute respiratory failure (PaO2/FiO2 <300), needing mechanical ventilation. Are expected to be require mechanical ventilation for more than 48 hours.
  2. Patients who are to receive enteral feeding via a gastric or post-pyloric feeding tube.
  3. Patients or their next-of-kin consent to participate in the study. -

Exclusion Criteria:

  1. Patients under the age of 18 years
  2. Patients with contra-indications to enteral feeding
  3. Patients receiving total parental nutrition
  4. Patients who are already enrolled in another study that may influence the outcome of this study.
  5. Patients who are not receiving active medical management or are expected to die within 24 hours at the time of study entry.
  6. Patients with diabetes mellitus, renal failure or liver failure.
  7. Patients or next-of-kin who do not consent to participate in the study. -
Both
18 Years and older
No
Contact: Megan Robertson, MBBS + 61 3 93427441 megan.robertson@mh.org.au
Contact: Deborah Barge + 61 3 93427710 deborah.barge@mh.org.au
Australia
 
NCT00256074
2003.263
 
 
Melbourne Health
 
Principal Investigator: Megan Robertson, MBBS Melbourne Health
Melbourne Health
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP