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

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ClinicalTrials.gov Identifier: NCT00256074
Recruitment Status : Terminated (Decision was made to terminate the project due to slower than anticipated recruitment and many of the investigators no longer being available.)
First Posted : November 21, 2005
Last Update Posted : April 12, 2017
Sponsor:
Information provided by:
Melbourne Health

Tracking Information
First Submitted Date  ICMJE November 17, 2005
First Posted Date  ICMJE November 21, 2005
Last Update Posted Date April 12, 2017
Study Start Date  ICMJE June 2004
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
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
 (submitted: November 17, 2005)
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
 (submitted: February 3, 2009)
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
 (submitted: November 17, 2005)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.

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, (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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Critically Ill
Intervention  ICMJE Procedure: Enteral feeding formula
Study Arms  ICMJE
  • Standard Therapy Group
    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.
    Intervention: Procedure: Enteral feeding formula
  • Alternative Therapy Group
    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.
    Intervention: Procedure: Enteral feeding formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: November 17, 2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256074
Other Study ID Numbers  ICMJE 2003.263
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Melbourne Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Megan Robertson, MBBS Melbourne Health
PRS Account Melbourne Health
Verification Date April 2017

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