Critical Illness, Enteral Nutrition
Conditions
Brief summary
The estimation of calorie needs during routine practice in critically ill patients is highly variable and the thermogenic effect of continuous delivery of enteral nutrition (EN) on overall calorie utilisation in critically ill adults is unknown. The TARGET-ME study is a substudy of the TARGET trial (NCT02306746). The TARGET trial provides the perfect opportunity to measure calorie utilisation via indirect calorimetry (IC) and ventilator-derived carbon dioxide production (VCO2) to compare measured calorie utilisation to estimation methods, determine the potential thermic effect of EN solutions with different energy concentrations and investigate any associations with outcome.
Interventions
DIETARY_SUPPLEMENTTARGET protocol EN 1.5 kcal/mL
Enteral nutrition
Sponsors
The Canberra Hospital
Royal Adelaide Hospital
Auckland City Hospital
Melbourne Health
Australian and New Zealand Intensive Care Research Centre
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must first meet the inclusion and none of the
Exclusion criteria
for the TARGET main trail (NCT02306746). The following additional criteria applies for this study when indirect calorimetry is being used: * Within 48 hours of randomisation to TARGET (first measurement only) * Fi02 \< 50% for the past 1 hour * Positive end expiratory pressure (PEEP) \< 12 mmHg for the past 1 hour * The IC test can be conducted within 48 hours of randomisation to TARGET * The patient is not considered agitated using the usual site assessment * There is a clinician available to complete the test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calorie difference in kcal | Up to day 28 | Difference in mean calorie delivery and mean measured calorie utilisation over the study period (expressed as a percentage of measured requirements received) in each study group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calorie difference in kcal in the whole study cohort | Up to day 28 | Calorie difference in kcal between mean calorie delivery and mean measured calorie utilisation over the study period (expressed as a percentage of measured requirements received) in the whole study cohort |
Other
| Measure | Time frame | Description |
|---|---|---|
| Calorie difference in kcal | Up to day 28 | Calorie difference in kcal between mean measured calorie utilisation and mean calorie requirements predicted by the estimation method used in TARGET and in routine clinical practice |
| Energy balance | Up to day 28 | Energy balance in both the intervention and standard care groups (with measured calorie utilisation as the reference) up until 4 weeks post randomisation |
| Degree of diet induced thermogenesis | Up to day 28 | measured as the difference between mean measured calorie utilisation in kcal between the two intervention groups |
| Correlation of energy expenditure (EE) assessed by IC and VCO2 compared to predictive equations estimates of EE | Up to day 28 | Correlation (bias, precision, accuracy rates) of EE assessed by IC and VCO2 compared to predictive equations estimates of EE |
Countries
Australia
Outcome results
None listed