The TARGET Protein Feasibility Study
The importance of nutrition in critical illness is widely recognised, yet there remains uncertainty about the optimal target for caloric requirements. The TARGET Protein Feasibility Trial will establish feasibility and inform a subsequent phase III randomised clinical trial to compare an intervention of augmented enteral protein delivery (i.e. as recommended by international guidelines) to standard care in mechanically ventilated critically ill adults.
The TARGET Protein Feasibility Study
Background
- Nutrition therapy is an essential standard of care for all ICU patients who are mechanically ventilated and remain in ICU for more than a few days
- Enteral nutrition (via a nasogastric tube) is usually initiated within 24 hours of ICU admission
- Loss of muscle mass and malnutrition is common among critically ill patients – 50% will not meet their nutritional targets while in the ICU. Nutritional Intervention can have a major impact on survival and recovery for these patients.
Facts
- Each year around 130,000 Australians are admitted to ICU at a daily cost of approximately $4000 per patient
- Critically ill patients require substantial resources and multiple interventions, some die and many of those who survive have delayed and compromised functional recovery which can persist for months or years
Aims
The primary aim is to establish treatment separation (protein delivered), with ‘augmented protein’ providing a dose of protein that is within guideline recommendations and ‘control’ representing usual standard care.
Methods
- A 120 patient, multi-centre, double-blinded, randomised, controlled, parallel-group, feasibility trial
- Eligible patients will be randomised 1:1 to receive TARGET Protein protocol formulation of either routine care formula (63g protein per 1000ml) or higher protein formula (100g protein per 1000ml). Calorie content in both formulations will be 1.25kcal/ml
- The trial will be conducted in 8 ICUs in Australia and New Zealand
Supported by: A Royal Adelaide Hospital Translation Grant & Nutricia Australia Pty Limited
Coordinating centre: The Royal Adelaide Hospital
Chief Investigator: A/Prof. Adam Deane, Intensive Care Unit, The Royal Melbourne Hospital
Contact: A/Prof. Adam Deane, Intensive Care Unit, The Royal Melbourne Hospital, Australia
Software: Spinnaker, Spiral Software
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Study Database
Sign in to the study (username + password needed)Study Database
The TARGET Protein Feasibility Trial is open and enrolling patients. If you have a username and password you can sign in from here.
ANZCTR
View this trial on the Australian and New Zealand Clinical Trial RegistryANZCTR
View this trial on the Australian and New Zealand Clinical Trial Registry.