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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Melbourne Health.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Melbourne Health

ClinicalTrials.gov Identifier:

NCT00256074

First received: November 17, 2005

Last updated: February 3, 2009

Last verified: February 2009

History of Changes

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation

Resource links provided by NLM:

MedlinePlus related topics: Nutritional Support

U.S. FDA Resources

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. [ Time Frame: patients will be followed until death or hospital discharge ]

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. [ Time Frame: patients will be followed until death or hospital discharge ]


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.

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.

Eligibility


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

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. -

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided


ClinicalTrials.gov Identifier:	NCT00256074 History of Changes
Other Study ID Numbers:	2003.263
Study First Received:	November 17, 2005
Last Updated:	February 3, 2009
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:


Critical Illness Disease Attributes Pathologic Processes

ClinicalTrials.gov processed this record on March 02, 2015

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