TARGET-Metabolic Effects

Study Overview
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Brief Summary
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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.

Official Title
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The Augmented Versus Routine Approach to Giving Energy Trial Metabolic Effects Sub-study (TARGET-ME)

Conditions
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Critical Illness, Enteral Nutrition

Intervention / Treatment
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* Dietary Supplement: TARGET protocol EN 1.5 kcal/mL


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: There is an air leak in the ventilation circuit (ie bubbling inter-costal catheters, cuff leak at the endotracheal tube The patient is receiving renal replacement therapy or extracorporeal membrane oxygenation at the time of measurement Has had surgery in the last 6 hours (if enough time within the 48 hour window, consider waiting until this criteria is less than 6 hours) If the patient has a traumatic brain injury, for the previous 6 hours, their intracranial pressures have been unstable and in the opinion of the treating intensivist are not controlled The treating clinician believes that the IC test will pose risk to the patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TARGET protocol EN 1.5 kcal/mL<br>Enteral (EN) feed 1.5 kcal/mL. Indirect calorimetry and/or VCO2 measurements will be taken periodically while in the TARGET main study | Dietary Supplement: TARGET protocol EN 1.5 kcal/mL<br>* Enteral nutrition<br>|
| Active Comparator: TARGET protocol EN 1.0 kcal/mL<br>Enteral feed 1.0 kcal/mL Indirect calorimetry and/or VCO2 measurements will be taken periodically while in the TARGET main study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |