TARGET Protein
The University of MelbourneDataset description
This dataset contains participant level data collected as part of the TARGET Protein Randomised Clinical Trial. TARGET Protein was a multicentre, cluster randomised, crossover, open label study conducted across eight intensive care units in Australia and New Zealand. The trial compared two isocaloric enteral nutrition formulae -augmented protein (100 g protein/L) versus usual protein (63 g protein/L)-to evaluate whether higher protein delivery during critical illness influences clinical outcomes, including number of free of the index hospital and alive at day 90. Data include baseline demographics, ICU admission characteristics, nutrition delivery parameters, treatment assignment by cluster period, clinical outcomes, ventilation and renal replacement therapy data, biochemical measures, and adverse events. The dataset reflects intention to treat populations across all trial periods, comprising 3,397 enrolled participants (1,681 augmented protein; 1,716 usual protein). Variables include: • Patient demographics, comorbidities, APACHE II scores, frailty scores • ICU admission reasons and diagnostic categories • Treatment allocation by cluster and period • Enteral nutrition dose, duration, protein and calorie delivery • Mechanical ventilation use, vasopressor/inotrope use, renal replacement therapy • Hospital and ICU length of stay, ventilation duration • Biochemical markers (e.g., urea concentrations) • Primary and secondary outcome measures (e.g., the number of days free of the index hospital and at day 90; survival to day 90) • Adverse events and protocol deviations JAMA.doi:10.1001/jama.2025.9110Date Information
Identifiers
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12621001484831
Funding
Other Collaborative groups, Central Adelaide Local Health Network
Scientific enquiries
A/Prof Adam Deane
Brief Summary
An intensive care unit (ICU) stay is associated with significant muscle wasting in up to 80% of critically ill patients. This muscle wasting results in ‘ICU-acquired weakness’ that is associated with slower weaning from ventilator support, longer time to discharge alive from ICU and hospital, higher in-hospital costs which persist well after discharge from the acute care setting. Nutrition therapy, delivered as liquid nutrition via a tube into the stomach, forms usual care for critically ill pat .... Read more
Key Inclusion Criteria
1) About to commence enteral nutrition
Key Exclusion Criteria
1. The treating clinician considers the study formulae to be contraindicated 2. The patient has previously participated in TARGET Protein Trial
Can healthy volunteers participate?
No
Population
Sample Size 3412
Min. age 16 Years
Max. age No limit
Sex Both males and females
Condition category Critical Illness
Condition code Diet and Nutrition
Intervention
Intervention code Treatment: Other
Intervention enteral nutrition (EN) - ‘Nutrison Protein Intense’ 1.26 kcal/ml and 100g protein per 1000 ml delivered via naso-enteric tube, delivered daily for up to 90 days. The goal rate for enteral nutrition will be as per usual site processes with the maximum goal rate of the enteral nutrition for both groups of 1 ml/kg ideal body weight (IBW / hour), delivered over 24 hours/day. This will ensure participant safety with no participant receiving excess protein, calories or volume.
Comparison
Control group Active
Control enteral nutrition (EN) - ‘Nutrison Protein Plus’ 1.25 kcal/ml and 63g protein per 1000ml delivered via naso-enteric tube, delivered daily for up to 90 days. The goal rate for enteral nutrition will be as per usual site processes with the maximum goal rate of the enteral nutrition for both groups of 1 ml/kg ideal body weight (IBW / hour), delivered over 24 hours/day. This will ensure participant safety with no participant receiving excess protein, calories or volume.
Outcomes
Outcome: Days free of the index hospital and alive at day-90 (Calculated as 90 and subtracting all days in hospital during the index hospital admission plus any readmissions to the index hospital within 90 days for which the patient remains in-hospital at 2400 h. Patients will be considered alive if they are alive at discharge from the index-hospital and there is no evidence of death before day 90 and after hospital death from the national death index. All deaths up to day 90 c .... Read more