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Completed

NCT Number: NCT03793244

TARGET-Metabolic Effects

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.

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Key information

Conditions

Critical Illness Disease Attributes Enteral Nutrition Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ANZIC-RC

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TARGET protocol EN 1.5 kcal/mL

Dietary Supplement

Enteral nutrition

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Collaborators

  • Auckland City Hospital
  • Melbourne Health
  • Royal Adelaide Hospital
  • The Canberra Hospital

Registry information

Official study title

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

Acronym: TARGET-ME

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2019
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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