Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity
DIRECT
GuiDIng Energy Provision Using indiREct CalorimeTry: a Pilot Feasibility Randomised Controlled Trial in Critically Ill Adults With Obesity
1 other identifier
interventional
60
2 countries
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedStudy Start
First participant enrolled
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedJuly 25, 2025
July 1, 2025
2.4 years
August 21, 2023
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (15)
Treatment separation in energy adequacy
Post-ICU period (up to day 28)
Protocol adherence
Post-ICU period (up to day 28)
Reasons for indirect calorimetry measurement non-completion
Up to day 28
Clinician acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)
Up to day 28
Patient acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)
Up to day 28
- +10 more secondary outcomes
Study Arms (2)
Individualised energy delivery
EXPERIMENTALEnergy 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.
Standard care nutrition
ACTIVE COMPARATOREnergy delivery will be according to predictive equation estimates and usual site practice from day 4 to 28 of hospital admission.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Ballarat Base Hospital, Grampians Health
Ballarat Central, Victoria, 3550, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Department of Critical Care Medicine, Auckland City Hospital
Auckland, 1023, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open-label trial. However, clinicians will be blinded to indirect calorimetry measurements in the control arm.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2023
First Posted
September 25, 2023
Study Start
October 2, 2023
Primary Completion
March 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
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