Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A multi-centre, prospective, two arm parallel feasibility pilot randomised controlled trial

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Open-label trial. However, clinicians will be blinded to indirect calorimetry measurements in the control arm.

Study Groups

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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.

Group Type EXPERIMENTAL

Indirect calorimetry

Intervention Type OTHER

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

Standard care nutrition

Energy delivery will be according to predictive equation estimates and usual site practice from day 4 to 28 of hospital admission.

Group Type ACTIVE_COMPARATOR

Indirect calorimetry (Standard care nutrition arm)

Intervention Type OTHER

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.

Interventions

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