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| Name | Class |
|---|---|
| The Canberra Hospital | OTHER |
| Royal Adelaide Hospital | OTHER |
| Auckland City Hospital | OTHER_GOV |
| Melbourne Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: TARGET protocol EN 1.5 kcal/mL | Enteral (EN) feed 1.5 kcal/mL. Indirect calorimetry and/or VCO2 measurements will be taken periodically while in the TARGET main study |
| |
| Active Comparator: TARGET protocol EN 1.0 kcal/mL | Enteral feed 1.0 kcal/mL Indirect calorimetry and/or VCO2 measurements will be taken periodically while in the TARGET main study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TARGET protocol EN 1.5 kcal/mL | Dietary Supplement | Enteral nutrition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calorie difference in kcal | 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 | Up to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Calorie difference in kcal in the whole study cohort | 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 | Up to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Calorie difference in kcal | 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 | Up to day 28 |
| Energy balance |
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:
Exclusion Criteria:
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Adult critically ill patients who are mechanically ventilated
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ANZIC-RC | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
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Energy balance in both the intervention and standard care groups (with measured calorie utilisation as the reference) up until 4 weeks post randomisation
| Up to day 28 |
| Degree of diet induced thermogenesis | measured as the difference between mean measured calorie utilisation in kcal between the two intervention groups | Up to day 28 |
| Correlation of energy expenditure (EE) assessed by IC and VCO2 compared to predictive equations estimates of EE | Correlation (bias, precision, accuracy rates) of EE assessed by IC and VCO2 compared to predictive equations estimates of EE | Up to day 28 |