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.

Study Overview

• Status: Terminated
• Conditions: Critically Ill
• Intervention / Treatment: Procedure: Enteral feeding formula

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Parkville,, Victoria, Australia, 3050
      • Intensive Care Unit, The Royal Melbourne Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine if high-fat low-carbohydrate enteral feeding reduces the carbon dioxide production and the respiratory quotient in patients with respiratory failure.	patients will be followed until death or hospital discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	patients will be followed until death or hospital discharge

Collaborators and Investigators

• Sponsor: Melbourne Health
• Investigators: Principal Investigator: Megan Robertson, MBBS, Melbourne Health

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: November 17, 2005
• First Submitted That Met QC Criteria: November 17, 2005
• First Posted (Estimate): November 21, 2005

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2003.263