Clinical trial NCT03793244: TARGET-Metabolic Effects
Official title: The Augmented Versus Routine Approach to Giving Energy Trial Metabolic Effects Sub-study (TARGET-ME)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Enteral Nutrition
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: The Canberra Hospital
name: Royal Adelaide Hospital
name: Auckland City Hospital
name: Melbourne Health
First posted: 2019-01-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult critically ill patients who are mechanically ventilated

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.


Eligibility criteria: 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

Primary outcomes:
measure: Calorie difference in kcal
timeFrame: Up to day 28
Secondary outcomes:
measure: Calorie difference in kcal in the whole study cohort
timeFrame: Up to day 28
Other outcomes:
measure: Calorie difference in kcal
timeFrame: Up to day 28
measure: Energy balance
timeFrame: Up to day 28
measure: Degree of diet induced thermogenesis
timeFrame: Up to day 28
measure: Correlation of energy expenditure (EE) assessed by IC and VCO2 compared to predictive equations estimates of EE
timeFrame: Up to day 28
Locations:
city: Melbourne
country: Australia
facility: ANZIC-RC
state: Victoria
Study officials:
References: