Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity (DIRECT)
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| ClinicalTrials.gov Identifier: NCT06053216 |
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Recruitment Status :
Recruiting
First Posted : September 25, 2023
Last Update Posted : April 9, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Critical Illness Obesity | Other: Indirect calorimetry Other: Indirect calorimetry (Standard care nutrition arm) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | A multi-centre, prospective, two arm parallel feasibility pilot randomised controlled trial |
| Masking: | None (Open Label) |
| Masking Description: | Open-label trial. However, clinicians will be blinded to indirect calorimetry measurements in the control arm. |
| Primary Purpose: | Other |
| Official Title: | GuiDIng Energy Provision Using indiREct CalorimeTry: a Pilot Feasibility Randomised Controlled Trial in Critically Ill Adults With Obesity |
| Actual Study Start Date : | October 2, 2023 |
| Estimated Primary Completion Date : | December 2024 |
| Estimated Study Completion Date : | March 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Individualised energy delivery
Energy delivery will be guided by indirect calorimetry, with the aim to meet 80-100% of the most recent energy expenditure measurement from day 4 to 28 of hospital admission.
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Other: Indirect calorimetry
Weekly indirect calorimetry measurements using the Q-NRG+ device will be used to guide energy delivery up to day 28 of hospital admission. |
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Active Comparator: Standard care nutrition
Energy delivery will be according to predictive equation estimates and usual site practice from day 4 to 28 of hospital admission.
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Other: Indirect calorimetry (Standard care nutrition arm)
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. |
- Feasibility: Recruitment rate [ Time Frame: During ICU admission (up to day 28) ]Patients per site, per month
- 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.
- Feasibility: Protocol adherence [ Time Frame: During ICU admission (up to day 28) ]Number of indirect calorimetry measurements completed/planned.
- 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
- Protocol adherence [ Time Frame: Post-ICU period (up to day 28) ]Number of indirect calorimetry measurements completed/ planned
- Reasons for indirect calorimetry measurement non-completion [ Time Frame: Up to day 28 ]Reported overall and separately for ventilated and canopy measurements
- 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.
- 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.
- Cumulative difference in energy delivery compared to measured energy expenditure [ Time Frame: Day 28 ]kcal; reported overall and separately for ventilated and canopy measurements
- Cumulative difference in energy delivery compared to prescribed energy expenditure [ Time Frame: Day 28 ]kcal; reported overall and separately for ventilated and canopy measurements
- 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.
- Handgrip strength [ Time Frame: Hospital discharge (up to day 28) ]Measured using a hand dynamometer
- Duration of mechanical ventilation [ Time Frame: Day 28 ]Duration of mechanical ventilation (days)
- ICU length of stay [ Time Frame: Day 28 ]Duration of ICU stay (days)
- Hospital length of stay [ Time Frame: Day 28 ]Duration of hospital stay (days)
- 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
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053216
| Contact: Oana Tatucu | +61 3 9905 6646 | Oana.Tatucu@monash.edu | |
| Contact: Emma Ridley | +61 3 9903 0350 | Emma.Ridley@monash.edu |
| Australia, New South Wales | |
| Royal Prince Alfred Hospital | Recruiting |
| Camperdown, New South Wales, Australia, 2050 | |
| Contact: Suzie Ferrie, Dr | |
| Australia, Victoria | |
| Ballarat Base Hospital, Grampians Health | Recruiting |
| Ballarat Central, Victoria, Australia, 3550 | |
| Contact: Tim Stewart | |
| The Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Oana Tatucu +61 3 9905 6646 oana.tatucu@monash.edu | |
| Responsible Party: | Australian and New Zealand Intensive Care Research Centre |
| ClinicalTrials.gov Identifier: | NCT06053216 |
| Other Study ID Numbers: |
ANZIC-RC/OT001 |
| First Posted: | September 25, 2023 Key Record Dates |
| Last Update Posted: | April 9, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data sharing requests will be considered following publication of the primary trial data on an individual basis by the trial management committee (the data custodians). Data sharing will only be considered for investigator-initiated, independent researchers who provide a written data evaluation proposal that is judged to be methodologically sound. A data sharing agreement will be required to detail conditions under which data is shared and used. Resulting publications should appropriately cite and acknowledge the original data custodians. Requests for data sharing are to be made to anzicrc@monash.edu and the corresponding author, Dr Oana Tatucu; oana.tatucu@monash.edu |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Critical care nutrition Indirect calorimetry |
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Obesity Critical Illness Overweight Overnutrition |
Nutrition Disorders Body Weight Disease Attributes Pathologic Processes |