Indirect Calorimetry
OtherWeekly indirect calorimetry measurements using the Q-NRG+ device will be used to guide energy delivery up to day 28 of hospital admission.
NCT Number: NCT06053216
The DIRECT trial is a prospective, multi-centre, two arm parallel feasibility pilot randomised controlled trial. The primary aim is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity.
The trial will recruit 60 mechanically ventilated patients from 4-6 ICUs in Australia and New Zealand.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Blacktown Hospital, Blacktown, New South Wales, Australia
Indirect calorimetry is the current reference standard for measuring energy expenditure during critical illness, allowing for personalisation of energy delivery. Use of indirect calorimetry may be important in mitigating under- and overfeeding and associated adverse outcomes. This may be particularly important in patients with obesity, where energy expenditure is difficult to estimate, and limited data is available on the optimal nutritional management of this subgroup.
Although access to indirect calorimetry is gradually improving, it remains an underutilised tool and skills required to complete and interpret measurements are limited which may hinder use and integration into practice. There is a resulting knowledge gap on the impact of indirect calorimetry on outcomes in comparison to standard care predictive equations.
A definitive and pragmatic trial is needed to assess the impact of guiding energy delivery with indirect calorimetry on patient outcomes. Importantly, confirming the feasibility of using indirect calorimetry to guide energy delivery is needed to define optimal measurement protocols prior to completion of a larger trial.
The primary aim of the DIRECT trial is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity. The secondary aim is to inform a larger trial by collecting process, nutrition, functional, clinical and safety outcomes.
The investigators will consider the main trial feasible to conduct if 2 of the following 3 feasibility criteria are achieved: (a) recruitment rate is ≥ 1 patient per calendar month; (b) between group separation of ≥20% in energy adequacy during ICU admission is achieved in relation to measured energy expenditure and; (c) the number of indirect calorimetry measurements completed/planned ≥60% during ICU admission.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly indirect calorimetry measurements using the Q-NRG+ device will be used to guide energy delivery up to day 28 of hospital admission.
Weekly indirect calorimetry measurements using the Q-NRG+ device will be conducted up to day 28 of hospital admission. In the standard care nutrition arm, clinicians will be blinded to indirect calorimetry measurements.
Time frame: During ICU admission (up to day 28)
Patients per site, per month
Time frame: During ICU admission (up to day 28)
Energy adequacy % will be calculated as daily energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage.
Time frame: During ICU admission (up to day 28)
Number of indirect calorimetry measurements completed/planned.
Time frame: Post-ICU period (up to day 28)
Energy adequacy % will be calculated as energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage
Time frame: Post-ICU period (up to day 28)
Number of indirect calorimetry measurements completed/ planned
Time frame: Up to day 28
Reported overall and separately for ventilated and canopy measurements
Time frame: Up to day 28
Reported separately for ventilated and canopy measurements. A combination of yes/no, multiple-choice and Likert scale (1 (minimum) - 5 (maximum)) questions are included.
Time frame: Up to day 28
Reported for canopy measurements only. A combination of yes/no, multiple-choice and Likert scale (1 (minimum) - 5 (maximum)) questions are included.
Time frame: Day 28
kcal; reported overall and separately for ventilated and canopy measurements
Time frame: Day 28
kcal; reported overall and separately for ventilated and canopy measurements
Time frame: Baseline, ICU (up to day 28) and hospital discharge (up to day 28)
Assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria where malnutrition diagnosis is based on meeting predefined phenotypic and etiologic criteria (PMID: 30181091). Severity of malnutrition (moderate or severe) is determined based on the phenotypic criterion related to severity of unintentional weight loss.
Time frame: Hospital discharge (up to day 28)
Measured using a hand dynamometer
Time frame: Day 28
Duration of mechanical ventilation (days)
Time frame: Day 28
Duration of ICU stay (days)
Time frame: Day 28
Duration of hospital stay (days)
Time frame: ICU discharge (up to day 28), in-hospital (up to day 28) and 90 day
ICU, in-hospital and 90 day mortality
Time frame: Day 90
Health related quality of life assessment using EQ5D-5L. Each dimension has 5 levels ranging from no problems (1) to extreme problems (5), there is no overall score. It also has a visual analogue scale (VAS) ranging 0-100 with 0 being worst imaginable health state and 100 being best imaginable health state
Time frame: Day 90
WHODAS is a 12 point disability assessment with a raw score range of 0-48. 0 is no disability and 48 being full disability
Australian and New Zealand Intensive Care Research Centre
Other
GuiDIng Energy Provision Using indiREct CalorimeTry: a Pilot Feasibility Randomised Controlled Trial in Critically Ill Adults With Obesity
Acronym: DIRECT
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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