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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06053216
Registration number
NCT06053216
Ethics application status
Date submitted
21/08/2023
Date registered
25/09/2023
Titles & IDs
Public title
Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity
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Scientific title
GuiDIng Energy Provision Using indiREct CalorimeTry: a Pilot Feasibility Randomised Controlled Trial in Critically Ill Adults With Obesity
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Secondary ID [1]
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ANZIC-RC/OT001
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Universal Trial Number (UTN)
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Trial acronym
DIRECT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility: Recruitment rate
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Assessment method [1]
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Patients per site, per month
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Timepoint [1]
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During ICU admission (up to day 28)
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Primary outcome [2]
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Feasibility: Treatment separation in energy adequacy
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Assessment method [2]
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Energy adequacy % will be calculated as daily energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage.
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Timepoint [2]
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During ICU admission (up to day 28)
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Primary outcome [3]
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Feasibility: Protocol adherence
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Assessment method [3]
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Number of indirect calorimetry measurements completed/planned.
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Timepoint [3]
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During ICU admission (up to day 28)
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Secondary outcome [1]
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Treatment separation in energy adequacy
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Assessment method [1]
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Energy adequacy % will be calculated as energy delivery (kcal)/ measured energy expenditure (kcal) and expressed as a percentage
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Timepoint [1]
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Post-ICU period (up to day 28)
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Secondary outcome [2]
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Protocol adherence
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Assessment method [2]
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Number of indirect calorimetry measurements completed/ planned
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Timepoint [2]
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Post-ICU period (up to day 28)
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Secondary outcome [3]
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Reasons for indirect calorimetry measurement non-completion
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Assessment method [3]
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Reported overall and separately for ventilated and canopy measurements
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Timepoint [3]
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Up to day 28
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Secondary outcome [4]
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Clinician acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)
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Assessment method [4]
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Reported separately for ventilated and canopy measurements. A combination of yes/no, multiple-choice and Likert scale (1 (minimum) - 5 (maximum)) questions are included.
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Timepoint [4]
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Up to day 28
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Secondary outcome [5]
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Patient acceptability relating to use of indirect calorimetry in routine clinical care (questionnaire)
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Assessment method [5]
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Reported for canopy measurements only. A combination of yes/no, multiple-choice and Likert scale (1 (minimum) - 5 (maximum)) questions are included.
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Timepoint [5]
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Up to day 28
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Secondary outcome [6]
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Cumulative difference in energy delivery compared to measured energy expenditure
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Assessment method [6]
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kcal; reported overall and separately for ventilated and canopy measurements
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Timepoint [6]
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Day 28
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Secondary outcome [7]
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Cumulative difference in energy delivery compared to prescribed energy expenditure
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Assessment method [7]
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kcal; reported overall and separately for ventilated and canopy measurements
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Timepoint [7]
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Day 28
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Secondary outcome [8]
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Nutritional status
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, ICU (up to day 28) and hospital discharge (up to day 28)
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Secondary outcome [9]
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Handgrip strength
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Assessment method [9]
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Measured using a hand dynamometer
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Timepoint [9]
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Hospital discharge (up to day 28)
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Secondary outcome [10]
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Duration of mechanical ventilation
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Assessment method [10]
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Duration of mechanical ventilation (days)
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Timepoint [10]
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Day 28
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Secondary outcome [11]
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ICU length of stay
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Assessment method [11]
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Duration of ICU stay (days)
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Timepoint [11]
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Day 28
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Secondary outcome [12]
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Hospital length of stay
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Assessment method [12]
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Duration of hospital stay (days)
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Timepoint [12]
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Day 28
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Secondary outcome [13]
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Survival
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Assessment method [13]
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ICU, in-hospital and 90 day mortality
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Timepoint [13]
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ICU discharge (up to day 28), in-hospital (up to day 28) and 90 day
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Secondary outcome [14]
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European Quality Of Life 5 Dimensions 5 Level (EQ5D-5L)
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Assessment method [14]
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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
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Timepoint [14]
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Day 90
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Secondary outcome [15]
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World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
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Assessment method [15]
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WHODAS is a 12 point disability assessment with a raw score range of 0-48. 0 is no disability and 48 being full disability
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Timepoint [15]
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Day 90
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Ballarat Base Hospital, Grampians Health - Ballarat Central
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Recruitment hospital [3]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3550 - Ballarat Central
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06053216
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Oana Tatucu
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Address
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Country
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Phone
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+61 3 9905 6646
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Data sharing requests will be considered following publication of the primary trial data on an individual basis by the trial management committee (the data custodians). Data sharing will only be considered for investigator-initiated, independent researchers who provide a written data evaluation proposal that is judged to be methodologically sound. A data sharing agreement will be required to detail conditions under which data is shared and used. Resulting publications should appropriately cite and acknowledge the original data custodians. Requests for data sharing are to be made to
[email protected]
and the corresponding author, Dr Oana Tatucu;
[email protected]
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06053216