Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity

Obesity Clinical Trial

— DIRECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053216
• Other study ID #: ANZIC-RC/OT001
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: Oana Tatucu
• Phone: +61 3 9905 6646
• Email: Oana.Tatucu[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Obesity

Intervention

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

Country	Name	City	State
Australia	Ballarat Base Hospital, Grampians Health	Ballarat Central	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Recruitment rate	Patients per site, per month	During ICU admission (up to day 28)
Primary	Feasibility: Treatment separation in energy adequacy	Energy adequacy % will be calculated as daily energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage.	During ICU admission (up to day 28)
Primary	Feasibility: Protocol adherence	Number of indirect calorimetry measurements completed/planned.	During ICU admission (up to day 28)
Secondary	Treatment separation in energy adequacy	Energy adequacy % will be calculated as energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage	Post-ICU period (up to day 28)
Secondary	Protocol adherence	Number of indirect calorimetry measurements completed/ planned	Post-ICU period (up to day 28)
Secondary	Reasons for indirect calorimetry measurement non-completion	Reported overall and separately for ventilated and canopy measurements	Up to day 28
Secondary	Clinician acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)	Reported separately for ventilated and canopy measurements. A combination of yes/no, multiple-choice and Likert scale (1 (minimum) - 5 (maximum)) questions are included.	Up to day 28
Secondary	Patient acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)	Reported for canopy measurements only. A combination of yes/no, multiple-choice and Likert scale (1 (minimum) - 5 (maximum)) questions are included.	Up to day 28
Secondary	Cumulative difference in energy delivery compared to measured energy expenditure	kcal; reported overall and separately for ventilated and canopy measurements	Day 28
Secondary	Cumulative difference in energy delivery compared to prescribed energy expenditure	kcal; reported overall and separately for ventilated and canopy measurements	Day 28
Secondary	Nutritional status	Assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria where malnutrition diagnosis is based on meeting predefined phenotypic and etiologic criteria (PMID: 30181091). Severity of malnutrition (moderate or severe) is determined based on the phenotypic criterion related to severity of unintentional weight loss.	Baseline, ICU (up to day 28) and hospital discharge (up to day 28)
Secondary	Handgrip strength	Measured using a hand dynamometer	Hospital discharge (up to day 28)
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation (days)	Day 28
Secondary	ICU length of stay	Duration of ICU stay (days)	Day 28
Secondary	Hospital length of stay	Duration of hospital stay (days)	Day 28
Secondary	Survival	ICU, in-hospital and 90 day mortality	ICU discharge (up to day 28), in-hospital (up to day 28) and 90 day
Secondary	European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L)	Health related quality of life assessment using EQ5D-5L. Each dimension has 5 levels ranging from no problems (1) to extreme problems (5), there is no overall score. It also has a visual analogue scale (VAS) ranging 0-100 with 0 being worst imaginable health state and 100 being best imaginable health state	Day 90
Secondary	World Health Organization Disability Assessment Schedule 2.0 (WHODAS)	WHODAS is a 12 point disability assessment with a raw score range of 0-48. 0 is no disability and 48 being full disability	Day 90