Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity (DIRECT)

Australian and New Zealand Intensive Care Research Centre

Status: Enrolling

Conditions: Critical Illness; Obesity

Treatments: Other: Indirect calorimetry; Other: Indirect calorimetry (Standard care nutrition arm)

Study type: Interventional

Funder types: Other

Identifiers

NCT06053216

ANZIC-RC/OT001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Individualised energy delivery

Experimental group

Description:

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.

Treatment:

Other: Indirect calorimetry

Standard care nutrition

Active Comparator group

Description:

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

Treatment:

Other: Indirect calorimetry (Standard care nutrition arm)