TARGET-Metabolic Effects (TARGET-ME)

• ClinicalTrials.gov Identifier: NCT03793244
• Recruitment Status: Completed
• First Posted: January 4, 2019
• Last Update Posted: January 4, 2019
• Sponsor: Australian and New Zealand Intensive Care Research Centre
• Collaborators: The Canberra Hospital; Royal Adelaide Hospital; Auckland City Hospital; Melbourne Health
• Information provided by (Responsible Party): anzicrc, Australian and New Zealand Intensive Care Research Centre

Study Description

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.

Condition or disease	Intervention/treatment
Critical Illness; Enteral Nutrition	Dietary Supplement: TARGET protocol EN 1.5 kcal/mL

Study Design

• Study Type: Observational
• Actual Enrollment: 42 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Augmented Versus Routine Approach to Giving Energy Trial Metabolic Effects Sub-study (TARGET-ME)
• Actual Study Start Date: July 1, 2017
• Actual Primary Completion Date: July 10, 2018
• Actual Study Completion Date: August 1, 2018

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Calorie difference in kcal [ Time Frame: 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 Outcome Measures :

1. Calorie difference in kcal in the whole study cohort [ Time Frame: 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 Outcome Measures:

1. Calorie difference in kcal [ Time Frame: 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
2. Energy balance [ Time Frame: 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
3. Degree of diet induced thermogenesis [ Time Frame: Up to day 28 ]
   measured as the difference between mean measured calorie utilisation in kcal between the two intervention groups
4. Correlation of energy expenditure (EE) assessed by IC and VCO2 compared to predictive equations estimates of EE [ Time Frame: Up to day 28 ]
   Correlation (bias, precision, accuracy rates) of EE assessed by IC and VCO2 compared to predictive equations estimates of EE

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Adult critically ill patients who are mechanically ventilated

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

Contacts and Locations

Locations

Australia, Victoria

ANZIC-RC

Melbourne, Victoria, Australia, 3004

Sponsors and Collaborators

Australian and New Zealand Intensive Care Research Centre

The Canberra Hospital

Royal Adelaide Hospital

Auckland City Hospital

Melbourne Health

More Information

• Responsible Party: anzicrc, ICU Nutrition Research Program Manager, Australian and New Zealand Intensive Care Research Centre
• ClinicalTrials.gov Identifier: NCT03793244
• Other Study ID Numbers: MC_001 V1 240217
• First Posted: January 4, 2019
• Last Update Posted: January 4, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes