A Phase 3 interventional study of TARGET protocol EN 1.5 kcal/mL and TARGET protocol EN 1.0 kcal/mL in Critical Illness, sponsored by Australian and New Zealand Intensive Care Research Centre. Completed at 46 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-13.
Sponsored by Australian and New Zealand Intensive Care Research Centre · Phase 3, Interventional, and Treatment
Nutrition therapy is an essential standard of care for all critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days.
The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial to determine if augmentation of calorie delivery using energy dense enteral nutrition in mechanically ventilated patients improves 90 day survival when compared to routine care.
Each year around 130,000 Australians are admitted to ICU at a daily cost of approximately $4000 per patient. Their care consumes close to 3 billion dollars per year. These critically ill patients are the sickest in the hospital. They 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.
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 with a formula containing 1 kcal/ml and prescribed at an approximate rate of 1 ml/kg/hour. However, standard enteral nutrition practice typically results in the delivery of only \~60% of the full-recommended calorie requirement.
Although prescribed calories can reliably be delivered using the intravenous route, the enteral route is preferred for a number of reasons and is recommended by all nutrition guidelines as first-line therapy. In particular, enteral nutrition is more physiological, less costly and associated with fewer infective complications. Delivery of nutrient into the gut also has beneficial effects on subsequent gut function and may reduce ongoing sepsis which can be fuelled by the movement of gut flora through a permeable mucosa that has not been exposed to nutrient. Intravenous nutrition is accordingly, generally used only when enteral feeding is impossible, or persistently limited. Although supplementing enteral with intravenous nutrition can increase calorie delivery, this has not been shown to have a therapeutic benefit and may worsen important clinical outcomes. This may be because adverse effects associated with intravenous nutrition counteract the benefits of increased calorie delivery.
Previous trials support the concept that optimising nutrition in the critically ill will improve outcome, however, the evidence is limited, inclusive and generally of low quality. It is extraordinary that there is not better (Level I) evidence to inform nutrition management in critically ill patients given the frequency of the intervention, the biologic rationale, the high mortality following ICU admission, the frequency of muscle wasting and the poor functional outcomes in survivors. This is especially true given the low cost of enteral nutrition (\~$23/day).
The investigators recently completed pilot study clearly achieved all the key criteria which, for a pharmaceutical product, would lead to a phase III trial, namely: 1. feasibility; 2. safety; 3. separation; 4. excellent recruitment rate; 5. successful blinding; 6. a signal for benefit.
A definitive study must now be done to establish whether 90-day survival and functional outcomes following critical illness may be improved by increased calorie delivery.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 4,000 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Australian and New Zealand Intensive Care Research Centre is the lead sponsor of 48 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Enteral (EN) feed 1.5 kcal/mL. The goal rate for administration of TARGET protocol EN is 1ml/kg/hr. To calculate the goal rate, weight is based on ideal body weight.
Dietary Supplement: TARGET protocol EN 1.5 kcal/mL
Enteral feed 1.0 kcal/mL The goal rate for administration of TARGET protocol EN is 1ml/kg/hr. To calculate the goal rate, weight is based on ideal body weight.
Dietary Supplement: TARGET protocol EN 1.0 kcal/mL
Enteral feed 1.5 kcal/mL
Enteral feed 1.0 kcal/mL
All cause mortality
Mortality status
Time frame: Day 90
Mortality
Mortality status
Time frame: At hospital discharge an average of 28 days
Mortality
Mortality status
Time frame: Day 28
Time from randomisation until death
Mortality status
Time frame: Day 180
Number of days alive and not in ICU
Mortality status
Time frame: Day 28
Number of days alive and not in hospital
Mortality status
Time frame: Day 28
Ventilator free days
Organ support status
Time frame: Day 28
Proportion of patients receiving vasopressor support
Organ support proportion
Time frame: Day 28
Vasopressor free days
Organ support status
Time frame: Day 28
Proportion of patients receiving any renal replacement therapy
Organ support proportion
Time frame: Day 28
Renal replacement therapy free days
Organ support status
Time frame: Day 28
Proportion of patients with positive blood cultures
Blood stream infection proportion
Time frame: Day 28
Proportion of patients requiring intravenous antimicrobials
Patients requiring intravenous antimicrobials
Time frame: Day 28
Mortality
Mortality status
Time frame: Day 180
Quality of life assessment
European Quality of Life 5 Dimensions
Time frame: Day 180
Functional outcomes for patients under 65 years in the work force
Questions from the Australian Labour Force Survey
Time frame: Day 180
Functional outcomes for patients under 65 years and not in the work force and patients 65 years and over living dependently
World Health Organization Disability Assessment Schedule 2.0
Time frame: Day 180
Functional outcomes for patients 65 years and over living independently
Adelaide Activities Profile
Time frame: Day 180
Cause-specific mortality
Mortality status
Time frame: Day 90
Plan to share: Undecided
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Australian and New Zealand Intensive Care Research Centre