Using indirect calorimetry to guide nutrition in critically ill obese patients
GuiDIng Energy Provision Using indiREct CalorimeTry: a Pilot Feasibility Randomised Controlled Trial in Critically Ill Adults With Obesity
This study tests if using a special method to measure how much energy critically ill obese patients need can help them get the right amount of nutrition while they're on a ventilator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Australian and New Zealand Intensive Care Research Centre Academic / other |
| Locations | 5 sites (Blacktown, New South Wales and 4 other locations) |
| Trial ID | NCT06053216 on ClinicalTrials.gov |
What this trial studies
The DIRECT trial is a multi-centre, feasibility pilot trial aimed at assessing the use of indirect calorimetry to personalize energy delivery in critically ill patients with obesity. It will recruit 60 mechanically ventilated patients from various ICUs in Australia and New Zealand. By measuring energy expenditure through indirect calorimetry, the study seeks to mitigate the risks of under- and overfeeding, which can adversely affect patient outcomes. The trial will also gather data on nutrition, clinical, and safety outcomes to inform a larger definitive trial in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a body mass index of 30 kg/m2 or higher, receiving invasive mechanical ventilation in the ICU.
Not a fit: Patients receiving extracorporeal membrane oxygenation support or those with major burns may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved nutritional management and outcomes for critically ill patients with obesity.
How similar studies have performed: While indirect calorimetry is an established method, this specific application in critically ill obese patients is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Blacktown, New South Wales and 4 other locations
- Blacktown Hospital — Blacktown, New South Wales, Australia (Recruiting)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
- Ballarat Base Hospital, Grampians Health — Ballarat Central, Victoria, Australia (Recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- Department of Critical Care Medicine, Auckland City Hospital — Auckland, New Zealand (Not_yet_recruiting)
Study contacts
- Study coordinator: Oana Tatucu
- Email: Oana.Tatucu@monash.edu
- Phone: +61 3 9905 6646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.