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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04896515
Registration number
NCT04896515
Ethics application status
Date submitted
15/04/2021
Date registered
21/05/2021
Titles & IDs
Public title
INTENT-Muscle (A Sub-study of INTENT)
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Scientific title
Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial - Muscle (a Sub-study of INTENT)
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Secondary ID [1]
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ANZIC-RC/ER003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critically Ill
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Other - Supplemental parenteral nutrition
Standard Nutrition Arm - In INTENT (the parent study) participants will be randomised to the i) Standard Nutrition or ii) Intensive Nutrition arm. A brief description of each is below.
In ICU:
1. After enrolment, patients allocated to the standard nutrition therapy (control) group will commence or continue nutrition via an enteral tube to a target rate according to unit protocol including the use of promotility agents and the placement of nasojejunal feeding tubes if required.
2. Parenteral Nutrition (PN) will only be used if the above methods have been attempted, or an absolute contraindication to enteral nutrition (EN) develops.
After ICU:
1. Nutrition management will be as per usual site management at that hospital.
Intensive Nutrition Arm - In ICU:
1. Supplemental PN will be commenced within 2 hours of randomisation. The starting dose will be determined by the amount of energy received in the 24 hours prior to randomisation
2. The need for the intervention will be based on the adequacy of nutrition provision and assessed daily until ICU discharge
3. If there is an interruption of EN for greater than 2 hours the PN must be run at 20 kcal/kg calculated body weight until EN is recommenced. After the interruption, EN should be recommenced as per local protocol.
After ICU:
1. An intensive nutrition intervention will be provided on the ward.
The goal of nutrition care across the hospital stay will be to ensure 80-100% of participant's estimated energy requirements are met.
Treatment: Other: Supplemental parenteral nutrition
Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
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Intervention code [1]
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Treatment: Other
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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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Phase angle
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Assessment method [1]
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To compare longitudinal changes in phase angle during hospital admission in patients randomised to both arms of INTENT.
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Timepoint [1]
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Hospital admission (censored at study day 28)
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Secondary outcome [1]
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Change in bioelectrical impedance spectroscopy (BIS) derived phase angle
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Assessment method [1]
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Change in BIS-derived phase angle from baseline to hospital discharge and every 7 days between
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Timepoint [1]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [2]
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Change in BIS-derived impedance ratio
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Assessment method [2]
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Change in BIS-derived impedance ratio from baseline to hospital discharge and every 7 days between.
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Timepoint [2]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [3]
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Change in BIS-derived fat-free mass
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Assessment method [3]
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Change in BIS-derived fat-free mass (kg) from baseline to hospital discharge and every 7 days between.
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Timepoint [3]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [4]
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Change in BIS-derived normally-hydrated lean tissue
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Assessment method [4]
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Change in BIS-derived normally-hydrated lean tissue (kg) (generated using the Chamney model) from baseline to hospital discharge and every 7 days between.
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Timepoint [4]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [5]
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Change in BIS-derived Cole model variable R infinity to R0
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Assessment method [5]
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Change in BIS-derived Cole model variable R infinity to R0 from baseline to hospital discharge and every 7 days between.
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Timepoint [5]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [6]
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Change in BIS-derived characteristic frequency (?c, a Cole model variable)
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Assessment method [6]
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Change in BIS-derived Cole model variable characteristic frequency (?c) from baseline to hospital discharge and every 7 days between.
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Timepoint [6]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [7]
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Change in BIS-derived membrane capacitance (a Cole model variable)
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Assessment method [7]
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Change in BIS-derived Cole model variable membrane capacitance from baseline to hospital discharge and every 7 days between.
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Timepoint [7]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [8]
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Change in BIS-derived extra-cellular water
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Assessment method [8]
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Change in BIS-derived extracellular water from baseline to hospital discharge and every 7 days between.
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Timepoint [8]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [9]
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Change in BIS-derived intracellular water
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Assessment method [9]
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Change in BIS-derived intracellular water from baseline to hospital discharge and every 7 days between.
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Timepoint [9]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [10]
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Change in ultrasound-derived Rectus femoris cross-sectional area
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Assessment method [10]
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Change in ultrasound-derived Rectus femoris cross-sectional area (cm2) from baseline to hospital discharge and at measurement points (every 7 days during hospital admission).
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Timepoint [10]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [11]
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Change in ultrasound-derived mid-upper arm muscle thickness
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Assessment method [11]
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Change in ultrasound-derived muscle thickness (in centimetres) at the mid-upper arm from baseline to hospital discharge and at measurement points (every 7 days during hospital admission).
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Timepoint [11]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [12]
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Change in ultrasound-derived bilateral quadriceps muscle thickness
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Assessment method [12]
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Change in ultrasound-derived bilateral quadriceps muscle thickness (in centimetres) from baseline to hospital discharge and at measurement points (every 7 days during hospital admission).
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Timepoint [12]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [13]
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Change in ultrasound-derived Rectus femoris echogenicity
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Assessment method [13]
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Change in ultrasound-derived Rectus femoris echogenicity from baseline to hospital discharge and at measurement points (every 7 days during hospital admission).
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Timepoint [13]
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Every 7 days during hospital admission (censored to study day 28)
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Secondary outcome [14]
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Muscle mass at ICU admission
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Assessment method [14]
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An estimate of whole-body muscularity at ICU admission (enrolment) will be assessed by ultrasound
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Timepoint [14]
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Baseline (Enrolment)
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Eligibility
Key inclusion criteria
* Randomised to the INTENT trial at a participating sub-study site
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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
* Patients will be excluded from the sub-study if they have any of the following:
* A pacemaker or electronic implantable device
* Missing limb(s)
* Unable to get adequate separation in the limbs (e.g. severe obesity)
* Inaccessible site(s) for electrode placement (e.g. major burns, trauma)
* Broken skin at the site(s) of electrode placement
* The treating clinician does not believe the study to be in the best interest of the patient
* Person responsible/Medical treatment decision maker is of non-English speaking background (therefore cannot provide informed consent) Note Before: If the Person responsible/medical treatment decision maker is of English speaking background but the patient is not (and the Person responsible/Medical treatment decision maker speaks the same language as the patient) you may continue assessing the patient for eligibility to INTENT-Muscle as the Person Responsible/Medical treatment decision maker can translate the Patient Information and Consent Form (PICF) and consent discussion with the patient in order to obtain continuing consent)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
21/06/2021
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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
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Actual
27/02/2023
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Sample size
Target
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Accrual to date
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Final
21
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Recruitment hospital [2]
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Nepean Hospital - Kingswood
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Recruitment hospital [3]
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Ballarat Base Hospital - Ballarat
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Recruitment hospital [4]
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Frankston Hospital - Frankston
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Recruitment hospital [5]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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3353 - Ballarat
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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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 currently recruiting randomised controlled trial "Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults" (INTENT, NCT03292237) is the first multi-centre trial to compare an intensive, individualised nutrition intervention to standard care for the duration of hospital admission in critically ill patients. INTENT-Muscle, is an observational longitudinal study nested within INTENT. The aim of INTENT-Muscle is to compare longitudinal changes in muscle health (assessed by bioimpedance and muscle ultrasound) in critically ill patients randomised to each arm of INTENT.
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Trial website
https://clinicaltrials.gov/study/NCT04896515
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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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Emma J Ridley, PhD
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Address
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Australian and New Zealand Intensive Care Research Centre
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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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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 scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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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/NCT04896515