TARGET-Metabolic Effects

Completed

• Conditions: Enteral Nutrition; Critical Illness
• Interventions: Dietary Supplement: TARGET protocol EN 1.5 kcal/mL

• Registration Number: NCT03793244
• Lead Sponsor: Australian and New Zealand Intensive Care Research Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-23
• Study Start: 2017-07-01
• Primary Completion: 2018-07-10
• Study Completion: 2018-08-01
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-02
• Last Update Submitted: 2019-01-02
• Study First Posted: 2019-01-04
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: TARGET protocol EN 1.5 kcal/mL	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

Primary Outcome Measures

Name	Time	Method
Calorie difference in kcal	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

Name	Time	Method
Calorie difference in kcal in the whole study cohort	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

Trial Locations

Locations (1)

ANZIC-RC; 🇦🇺 Melbourne, Victoria, Australia