Clinical trial NCT06053216: Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity
Official title: GuiDIng Energy Provision Using indiREct CalorimeTry: a Pilot Feasibility Randomised Controlled Trial in Critically Ill Adults With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Obesity
Keywords: Critical care nutrition
Indirect calorimetry
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-centre, prospective, two arm parallel feasibility pilot randomised controlled trial
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Feasibility: Recruitment rate
timeFrame: During ICU admission (up to day 28)
measure: Feasibility: Treatment separation in energy adequacy
timeFrame: During ICU admission (up to day 28)
measure: Feasibility: Protocol adherence
timeFrame: During ICU admission (up to day 28)
Secondary outcomes:
measure: Treatment separation in energy adequacy
timeFrame: Post-ICU period (up to day 28)
measure: Protocol adherence
timeFrame: Post-ICU period (up to day 28)
measure: Reasons for indirect calorimetry measurement non-completion
timeFrame: Up to day 28
measure: Clinician acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)
timeFrame: Up to day 28
measure: Patient acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)
timeFrame: Up to day 28
measure: Cumulative difference in energy delivery compared to measured energy expenditure
timeFrame: Day 28
measure: Cumulative difference in energy delivery compared to prescribed energy expenditure
timeFrame: Day 28
measure: Nutritional status
timeFrame: Baseline, ICU (up to day 28) and hospital discharge (up to day 28)
measure: Handgrip strength
timeFrame: Hospital discharge (up to day 28)
measure: Duration of mechanical ventilation
timeFrame: Day 28
measure: ICU length of stay
timeFrame: Day 28
measure: Hospital length of stay
timeFrame: Day 28
measure: Survival
timeFrame: ICU discharge (up to day 28), in-hospital (up to day 28) and 90 day
measure: European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L)
timeFrame: Day 90
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
timeFrame: Day 90
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Ballarat Central
country: Australia
facility: Ballarat Base Hospital, Grampians Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
References: