TARGET Protein Feasibility Study: a prospective, blinded, parallel group, randomised controlled trial to assess the feasibility of conducting a phase III trial of protein targets in critically ill adults
- Conditions
- Critical IllnessDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12618001829202
- Lead Sponsor
- Professor Marianne Chapman
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1.Aged greater than or equal to 18 years old
2.Receiving invasive mechanical ventilation
3.About to commence EN or EN commenced within the previous 12 hours
4.Expected to be receiving EN in ICU beyond the calendar day following randomisation
1.Expected to be receiving any oral nutrition before the calendar day following randomisation
2.Any EN or PN received for >12 hours in any ICU admission in this hospital episode
3.Previously enrolled in this study
4.Treating clinician considers the EN goal rate (i.e. 1ml/kg of ideal body weight (IBW) per hour) to be clinically contraindicated e.g. requirement for fluid restriction
5.Treating clinician considers that either dose of protein delivered in this study is unsuitable for the patient.
6.Requirement for specific nutritional therapy as determined by the treating doctor or dietitian i.e. protocol EN not considered to be in the best interest of the subject
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean daily protein delivery (g/kg IBW/day) and group separation by study randomisation.<br>The overall protein delivery will be calculated as total intake divided by the number of days fed and expressed as intake per 24 h - feasibility outcome[Daily during up to 28 days of intervention]
- Secondary Outcome Measures
Name Time Method