TARGET-Metabolic Effects (TARGET-ME)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Enteral Nutrition
• Intervention / Treatment: Dietary supplement: TARGET protocol EN 1.5 kcal/mL

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • ANZIC-RC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult critically ill patients who are mechanically ventilated

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Dietary supplement: TARGET protocol EN 1.5 kcal/mL; Enteral nutrition
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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Australian and New Zealand Intensive Care Research Centre
• Collaborators: Melbourne Health; Royal Adelaide Hospital; Auckland City Hospital; The Canberra Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): July 10, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: April 23, 2017
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (ACTUAL): January 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: MC_001 V1 240217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No