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

This study is currently recruiting participants.
Verified by Melbourne Health, February 2006

Sponsored by: Melbourne Health
Information provided by: Melbourne Health
ClinicalTrials.gov Identifier: NCT00256074
  Purpose

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.


Condition Intervention
Critically Ill Patients Who Require Mechanical Ventilation.
Procedure: Enteral feeding formula

MedlinePlus related topics:   Nutritional Support   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation

Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • To determine if high-fat low-carbohydrate enteral feeding reduces the carbon dioxide production and the respiratory quotient in patients with respiratory failure.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment:   30
Study Start Date:   June 2004

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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. -
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256074

Contacts
Contact: Megan Robertson, MBBS     + 61 3 93427441     megan.robertson@mh.org.au    
Contact: Deborah Barge     + 61 3 93427710     deborah.barge@mh.org.au    

Locations
Australia, Victoria
Intensive Care Unit, The Royal Melbourne Hospital,     Recruiting
      Parkville, Victoria, Australia, 3050
      Contact: Megan Robertson, MBBS     +61 3 93427441     megan.robertson@mh.org.au    
      Contact: Deborah Barge     +61 3 93427710     deborah.barge@mh.org.au    
      Principal Investigator: Megan Robertson, MBBS            

Sponsors and Collaborators
Melbourne Health

Investigators
Principal Investigator:     Megan Robertson, MBBS     Melbourne Health    
  More Information


Study ID Numbers:   2003.263
First Received:   November 17, 2005
Last Updated:   February 2, 2006
ClinicalTrials.gov Identifier:   NCT00256074
Health Authority:   Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:
Critical Illness

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 19, 2008




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