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Completed

NCT Number: NCT06053216

Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blacktown Hospital, Blacktown, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult (≥ 18 years) patients
  • Body mass index ≥30 kg/m2
  • Between day 3 and 6 of index ICU admission
  • Receiving invasive mechanical ventilation
  • Receiving enteral or parenteral nutrition

Exclusion criteria

  • Receiving extracorporeal membrane oxygenation support
  • Major burns (≥20% total body surface area)
  • Unable to perform indirect calorimetry within 24 hours of randomisation
  • Known pregnancy
  • Death is imminent
  • Treating clinician believes the study is not in the best interest of the patient

Treatment and study plan

Indirect Calorimetry

Other

Weekly indirect calorimetry measurements using the Q-NRG+ device will be used to guide energy delivery up to day 28 of hospital admission.

Indirect calorimetry (Standard care nutrition arm)

Other

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.

Primary outcomes

  1. Feasibility: Recruitment rate

    Time frame: During ICU admission (up to day 28)

    Patients per site, per month

  2. Feasibility: Treatment separation in energy adequacy

    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.

  3. Feasibility: Protocol adherence

    Time frame: During ICU admission (up to day 28)

    Number of indirect calorimetry measurements completed/planned.

Secondary outcomes

  1. Treatment separation in energy adequacy

    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

  2. Protocol adherence

    Time frame: Post-ICU period (up to day 28)

    Number of indirect calorimetry measurements completed/ planned

  3. Reasons for indirect calorimetry measurement non-completion

    Time frame: Up to day 28

    Reported overall and separately for ventilated and canopy measurements

  4. Clinician acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)

    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.

  5. Patient acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)

    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.

  6. Cumulative difference in energy delivery compared to measured energy expenditure

    Time frame: Day 28

    kcal; reported overall and separately for ventilated and canopy measurements

  7. Cumulative difference in energy delivery compared to prescribed energy expenditure

    Time frame: Day 28

    kcal; reported overall and separately for ventilated and canopy measurements

  8. Nutritional status

    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.

  9. Handgrip strength

    Time frame: Hospital discharge (up to day 28)

    Measured using a hand dynamometer

  10. Duration of mechanical ventilation

    Time frame: Day 28

    Duration of mechanical ventilation (days)

  11. ICU length of stay

    Time frame: Day 28

    Duration of ICU stay (days)

  12. Hospital length of stay

    Time frame: Day 28

    Duration of hospital stay (days)

  13. Survival

    Time frame: ICU discharge (up to day 28), in-hospital (up to day 28) and 90 day

    ICU, in-hospital and 90 day mortality

  14. European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L)

    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

  15. World Health Organization Disability Assessment Schedule 2.0 (WHODAS)

    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

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Registry information

Official study title

GuiDIng Energy Provision Using indiREct CalorimeTry: a Pilot Feasibility Randomised Controlled Trial in Critically Ill Adults With Obesity

Acronym: DIRECT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 25, 2023
Registry last updated
May 22, 2026

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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