TARGET-Metabolic Effects

NCT03793244 | Completed

• 1 other identifier: MC_001 V1 240217
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Calorie difference in kcal in the whole study cohort

  Up to day 28

Other Outcomes (4)

• Calorie difference in kcal

  Up to day 28

• Energy balance

  Up to day 28

• Degree of diet induced thermogenesis

  Up to day 28

Study Arms (2)

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

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

Interventions

TARGET protocol EN 1.5 kcal/mL DIETARY_SUPPLEMENT

Enteral nutrition

Experimental: TARGET protocol EN 1.5 kcal/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult critically ill patients who are mechanically ventilated

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead
• The Canberra Hospital: collaborator
• Royal Adelaide Hospital: collaborator
• Auckland City Hospital: collaborator
• Melbourne Health: collaborator

Study Sites (1)

ANZIC-RC

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU Nutrition Research Program Manager

Study Record Dates

• First Submitted: April 23, 2017
• First Posted: January 4, 2019
• Study Start: July 1, 2017
• Primary Completion: July 10, 2018
• Study Completion: August 1, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)