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

NCT00256074 | Terminated

• 1 other identifier: 2003.263
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

  patients will be followed until death or hospital discharge

Study Arms (2)

Standard Therapy Group

OTHER

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

OTHER

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

Interventions

Enteral feeding formula PROCEDURE

Alternative Therapy Group; Standard Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Melbourne Health: lead

Study Sites (1)

Intensive Care Unit, The Royal Melbourne Hospital,

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan Robertson, MBBS

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: June 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

AU (1)