TARGET-Metabolic Effects

Critical Illness Clinical Trial

— TARGET-ME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793244
• Other study ID #: MC_001 V1 240217
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: January 2019
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 1, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Enteral Nutrition

Intervention

Dietary Supplement:
• TARGET protocol EN 1.5 kcal/mL
Enteral nutrition

Locations

Country	Name	City	State
Australia	ANZIC-RC	Melbourne	Victoria

Sponsors (5)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	Auckland City Hospital, Melbourne Health, Royal Adelaide Hospital, The Canberra Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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