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

Primary Purpose

Critically Ill

Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Enteral feeding formula
Sponsored by
Melbourne Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Patients who are to receive enteral feeding via a gastric or post-pyloric feeding tube. Patients or their next-of-kin consent to participate in the study. - Exclusion Criteria: Patients under the age of 18 years Patients with contra-indications to enteral feeding Patients receiving total parental nutrition Patients who are already enrolled in another study that may influence the outcome of this study. Patients who are not receiving active medical management or are expected to die within 24 hours at the time of study entry. Patients with diabetes mellitus, renal failure or liver failure. Patients or next-of-kin who do not consent to participate in the study. -

Sites / Locations

  • Intensive Care Unit, The Royal Melbourne Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Standard Therapy Group

Alternative Therapy Group

Arm Description

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.

Outcomes

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 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.

Full Information

First Posted
November 17, 2005
Last Updated
April 10, 2017
Sponsor
Melbourne Health
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1. Study Identification

Unique Protocol Identification Number
NCT00256074
Brief Title
The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation
Official Title
The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Decision was made to terminate the project due to slower than anticipated recruitment and many of the investigators no longer being available.
Study Start Date
June 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Melbourne Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Therapy Group
Arm Type
Other
Arm Description
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.
Arm Title
Alternative Therapy Group
Arm Type
Other
Arm Description
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 Type
Procedure
Intervention Name(s)
Enteral feeding formula
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patients who are to receive enteral feeding via a gastric or post-pyloric feeding tube. Patients or their next-of-kin consent to participate in the study. - Exclusion Criteria: Patients under the age of 18 years Patients with contra-indications to enteral feeding Patients receiving total parental nutrition Patients who are already enrolled in another study that may influence the outcome of this study. Patients who are not receiving active medical management or are expected to die within 24 hours at the time of study entry. Patients with diabetes mellitus, renal failure or liver failure. Patients or next-of-kin who do not consent to participate in the study. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Robertson, MBBS
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit, The Royal Melbourne Hospital,
City
Parkville,
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia

12. IPD Sharing Statement

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

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