DIRECT
GuiDIng energy provision using indiREct CalorimeTry: a pilot feasibility randomised controlled trial in critically ill adults with obesity
DIRECT is a multi-centre, two arm parallel feasibility pilot randomised controlled trial in 60 mechanically ventilated patients from 4 Intensive Care Units (ICUs) in Australia and New Zealand. Aim: The primary aim is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity. |  |
Rationale: Indirect calorimetry is the current reference standard for determining 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.
Study Progress: Currently recruiting.
Registration: ClinicalTrials.gov NCT06053216.
Co-enrolment: Co-enrolment in any other interventional nutrition study is not permitted. Co-enrolment in observational nutrition studies and interventional non-nutrition studies will be considered by the Management Committee as required.