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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
OTHER
Phase
- NA
Study ID
NCT06053216
Intervention or treatment
OTHER: Indirect calorimetry
OTHER: Indirect calorimetry (Standard care nutrition arm)
Conditions
- Critical Illness
- Obesity
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Research sites nearby
Closest Location:
Blacktown Hospital
Select from list below to view details:
Blacktown Hospital
Blacktown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Ballarat Base Hospital, Grampians Health
Ballarat Central, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Australian and New Zealand Intensive Care Research Centre
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Individualised energy delivery
| Other: Indirect calorimetry |
ACTIVE_COMPARATOR: Standard care nutrition
| Other: Indirect calorimetry (Standard care nutrition arm) |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Recruitment rate | Patients per site, per month | During ICU admission (up to day 28) |
| Feasibility: Treatment separation in energy adequacy | Energy adequacy % will be calculated as daily energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage. | During ICU admission (up to day 28) |
| Feasibility: Protocol adherence | Number of indirect calorimetry measurements completed/planned. | During ICU admission (up to day 28) |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Treatment separation in energy adequacy | Energy adequacy % will be calculated as energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage | Post-ICU period (up to day 28) |
| Protocol adherence | Number of indirect calorimetry measurements completed/ planned | Post-ICU period (up to day 28) |
| Reasons for indirect calorimetry measurement non-completion | Reported overall and separately for ventilated and canopy measurements | Up to day 28 |
| Clinician acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire) | Reported separately for ventilated and canopy measurements. A combination of yes/no, multiple-choice and Likert scale (1 (minimum) - 5 (maximum)) questions are included. | Up to day 28 |
| Patient acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire) | Reported for canopy measurements only. A combination of yes/no, multiple-choice and Likert scale (1 (minimum) - 5 (maximum)) questions are included. | Up to day 28 |
| Cumulative difference in energy delivery compared to measured energy expenditure | kcal; reported overall and separately for ventilated and canopy measurements | Day 28 |
| Cumulative difference in energy delivery compared to prescribed energy expenditure | kcal; reported overall and separately for ventilated and canopy measurements | Day 28 |
| Nutritional status | 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. | Baseline, ICU (up to day 28) and hospital discharge (up to day 28) |
| Handgrip strength | Measured using a hand dynamometer | Hospital discharge (up to day 28) |
| Duration of mechanical ventilation | Duration of mechanical ventilation (days) | Day 28 |
| ICU length of stay | Duration of ICU stay (days) | Day 28 |
| Hospital length of stay | Duration of hospital stay (days) | Day 28 |
| Survival | ICU, in-hospital and 90 day mortality | ICU discharge (up to day 28), in-hospital (up to day 28) and 90 day |
| European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L) | 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 | Day 90 |
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS) | WHODAS is a 12 point disability assessment with a raw score range of 0-48. 0 is no disability and 48 being full disability | Day 90 |
References
Clinical Trials Gov: Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With ObesityOther trials to consider
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