RecruitingNot ApplicableNCT06053216

Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity

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


Sponsor

Australian and New Zealand Intensive Care Research Centre

Enrollment

60 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The DIRECT trial is a feasibility study testing whether using indirect calorimetry — a device that measures how many calories a critically ill patient actually burns — to guide nutrition delivery in ICU patients with obesity is practical and can be done consistently across multiple hospitals in Australia and New Zealand. Standard nutrition guidelines use mathematical formulas to estimate calorie needs, but these estimates may be inaccurate in patients with obesity, and personalized energy delivery may improve outcomes. Eligible participants are adult ICU patients aged 18 or older with a BMI of 30 or higher, who are between days 3–6 of their ICU stay, on a mechanical ventilator, and receiving enteral or parenteral (tube or IV) nutrition; those on ECMO or with burns covering more than 20% of the body are excluded. Participation involves being randomized to receive nutrition based on indirect calorimetry measurements or standard formula-based care, with clinical and nutritional outcomes tracked throughout the ICU stay. This summary was prepared using AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIndirect calorimetry

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

OTHERIndirect 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.


Locations(5)

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

Department of Critical Care Medicine, Auckland City Hospital

Auckland, New Zealand

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NCT06053216


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