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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06053216




Registration number
NCT06053216
Ethics application status
Date submitted
21/08/2023
Date registered
25/09/2023
Date last updated
9/04/2024

Titles & IDs
Public title
Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity
Scientific title
GuiDIng Energy Provision Using indiREct CalorimeTry: a Pilot Feasibility Randomised Controlled Trial in Critically Ill Adults With Obesity
Secondary ID [1] 0 0
ANZIC-RC/OT001
Universal Trial Number (UTN)
Trial acronym
DIRECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Indirect calorimetry
Other interventions - Indirect calorimetry (Standard care nutrition arm)

Experimental: 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.

Active Comparator: Standard care nutrition - Energy delivery will be according to predictive equation estimates and usual site practice from day 4 to 28 of hospital admission.


Other interventions: 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.

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility: Recruitment rate
Timepoint [1] 0 0
During ICU admission (up to day 28)
Primary outcome [2] 0 0
Feasibility: Treatment separation in energy adequacy
Timepoint [2] 0 0
During ICU admission (up to day 28)
Primary outcome [3] 0 0
Feasibility: Protocol adherence
Timepoint [3] 0 0
During ICU admission (up to day 28)
Secondary outcome [1] 0 0
Treatment separation in energy adequacy
Timepoint [1] 0 0
Post-ICU period (up to day 28)
Secondary outcome [2] 0 0
Protocol adherence
Timepoint [2] 0 0
Post-ICU period (up to day 28)
Secondary outcome [3] 0 0
Reasons for indirect calorimetry measurement non-completion
Timepoint [3] 0 0
Up to day 28
Secondary outcome [4] 0 0
Clinician acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)
Timepoint [4] 0 0
Up to day 28
Secondary outcome [5] 0 0
Patient acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)
Timepoint [5] 0 0
Up to day 28
Secondary outcome [6] 0 0
Cumulative difference in energy delivery compared to measured energy expenditure
Timepoint [6] 0 0
Day 28
Secondary outcome [7] 0 0
Cumulative difference in energy delivery compared to prescribed energy expenditure
Timepoint [7] 0 0
Day 28
Secondary outcome [8] 0 0
Nutritional status
Timepoint [8] 0 0
Baseline, ICU (up to day 28) and hospital discharge (up to day 28)
Secondary outcome [9] 0 0
Handgrip strength
Timepoint [9] 0 0
Hospital discharge (up to day 28)
Secondary outcome [10] 0 0
Duration of mechanical ventilation
Timepoint [10] 0 0
Day 28
Secondary outcome [11] 0 0
ICU length of stay
Timepoint [11] 0 0
Day 28
Secondary outcome [12] 0 0
Hospital length of stay
Timepoint [12] 0 0
Day 28
Secondary outcome [13] 0 0
Survival
Timepoint [13] 0 0
ICU discharge (up to day 28), in-hospital (up to day 28) and 90 day
Secondary outcome [14] 0 0
European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L)
Timepoint [14] 0 0
Day 90
Secondary outcome [15] 0 0
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
Timepoint [15] 0 0
Day 90

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Ballarat Base Hospital, Grampians Health - Ballarat Central
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3550 - Ballarat Central
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06053216
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Oana Tatucu
Address 0 0
Country 0 0
Phone 0 0
+61 3 9905 6646
Fax 0 0
Email 0 0
Oana.Tatucu@monash.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06053216