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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Critically Ill Procedure: Enteral feeding formula Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation
Study Start Date : June 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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.
 Procedure: Enteral feeding formula


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256074


Locations
Australia, Victoria
Intensive Care Unit, The Royal Melbourne Hospital,
Parkville,, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Megan Robertson, MBBS Melbourne Health
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00256074     History of Changes
Other Study ID Numbers: 2003.263
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes