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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)
Scientific title
Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial - Muscle (a Sub-study of INTENT)
Secondary ID [1] 0 0
ANZIC-RC/ER003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase angle
Timepoint [1] 0 0
Hospital admission (censored at study day 28)
Secondary outcome [1] 0 0
Change in bioelectrical impedance spectroscopy (BIS) derived phase angle
Timepoint [1] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [2] 0 0
Change in BIS-derived impedance ratio
Timepoint [2] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [3] 0 0
Change in BIS-derived fat-free mass
Timepoint [3] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [4] 0 0
Change in BIS-derived normally-hydrated lean tissue
Timepoint [4] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [5] 0 0
Change in BIS-derived Cole model variable R infinity to R0
Timepoint [5] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [6] 0 0
Change in BIS-derived characteristic frequency (?c, a Cole model variable)
Timepoint [6] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [7] 0 0
Change in BIS-derived membrane capacitance (a Cole model variable)
Timepoint [7] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [8] 0 0
Change in BIS-derived extra-cellular water
Timepoint [8] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [9] 0 0
Change in BIS-derived intracellular water
Timepoint [9] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [10] 0 0
Change in ultrasound-derived Rectus femoris cross-sectional area
Timepoint [10] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [11] 0 0
Change in ultrasound-derived mid-upper arm muscle thickness
Timepoint [11] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [12] 0 0
Change in ultrasound-derived bilateral quadriceps muscle thickness
Timepoint [12] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [13] 0 0
Change in ultrasound-derived Rectus femoris echogenicity
Timepoint [13] 0 0
Every 7 days during hospital admission (censored to study day 28)
Secondary outcome [14] 0 0
Muscle mass at ICU admission
Timepoint [14] 0 0
Baseline (Enrolment)

Eligibility
Key inclusion criteria
* Randomised to the INTENT trial at a participating sub-study site
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/02/2023
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [4] 0 0
Frankston Hospital - Frankston
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
3353 - Ballarat
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emma J Ridley, PhD
Address 0 0
Australian and New Zealand Intensive Care Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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