An observational study in Critically Ill, sponsored by Australian and New Zealand Intensive Care Research Centre. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Australian and New Zealand Intensive Care Research Centre · Observational
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.
Background: Critically ill patients may experience debilitating loss of muscle mass and strength, leading to substantial functional impairments both during and long after hospitalisation. Little is known about what therapies may attenuate deterioration of muscle health (muscle mass and muscle quality) in this setting but nutrition is thought to be important, based on the physiological response to critical illness.
The currently recruiting randomised controlled trial (RCT) "Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults" (ClinicalTrials.gov Identifier: NCT03292237) is the first multi-centre trial to provide an individualised nutrition intervention for the duration of hospital admission in critically ill patients. Combining the most promising and novel bedside techniques for objectively measuring muscle health (bioimpedance technology and ultrasound) with a whole hospital nutrition intervention has never been done before, and will provide crucial data to understand the relationship between nutrition delivery and changes in muscularity from ICU admission to hospital discharge.
Aim: To explore changes in muscle health in response to an individualised nutrition intervention and in association with clinical and functional outcomes, using clinically applicable bedside techniques.
Secondary aims:
In both arms of INTENT to:
Hypothesis: In critically ill patients receiving individualised nutrition care for the duration of hospital admission (censored at study day 28), declines in phase angle and muscle health will be attenuated compared to patients receiving standard nutritional care.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 21 is below the median of 140 across 814 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Australian and New Zealand Intensive Care Research Centre is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Sixty to eighty critically ill patients from up to 6 participating INTENT sites in Australia and New Zealand will be recruited to INTENT-Muscle
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will be excluded from the sub-study if they have any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Dietary Supplement: Supplemental parenteral nutrition
Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
Phase angle
To compare longitudinal changes in phase angle during hospital admission in patients randomised to both arms of INTENT.
Time frame: Hospital admission (censored at study day 28)
Change in bioelectrical impedance spectroscopy (BIS) derived phase angle
Change in BIS-derived phase angle from baseline to hospital discharge and every 7 days between
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived impedance ratio
Change in BIS-derived impedance ratio from baseline to hospital discharge and every 7 days between.
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived fat-free mass
Change in BIS-derived fat-free mass (kg) from baseline to hospital discharge and every 7 days between.
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived normally-hydrated lean tissue
Change in BIS-derived normally-hydrated lean tissue (kg) (generated using the Chamney model) from baseline to hospital discharge and every 7 days between.
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived Cole model variable R infinity to R0
Change in BIS-derived Cole model variable R infinity to R0 from baseline to hospital discharge and every 7 days between.
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived characteristic frequency (ωc, a Cole model variable)
Change in BIS-derived Cole model variable characteristic frequency (ωc) from baseline to hospital discharge and every 7 days between.
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived membrane capacitance (a Cole model variable)
Change in BIS-derived Cole model variable membrane capacitance from baseline to hospital discharge and every 7 days between.
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived extra-cellular water
Change in BIS-derived extracellular water from baseline to hospital discharge and every 7 days between.
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived intracellular water
Change in BIS-derived intracellular water from baseline to hospital discharge and every 7 days between.
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in ultrasound-derived Rectus femoris cross-sectional area
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).
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in ultrasound-derived mid-upper arm muscle thickness
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).
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in ultrasound-derived bilateral quadriceps muscle thickness
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).
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in ultrasound-derived Rectus femoris echogenicity
Change in ultrasound-derived Rectus femoris echogenicity from baseline to hospital discharge and at measurement points (every 7 days during hospital admission).
Time frame: Every 7 days during hospital admission (censored to study day 28)
Muscle mass at ICU admission
An estimate of whole-body muscularity at ICU admission (enrolment) will be assessed by ultrasound
Time frame: Baseline (Enrolment)
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jun 2021 to primary completion in Feb 2023, 20 months.
Of 439 non-industry observational studies under Critical Illness, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's 20 months is below that.
Counting every sponsor, half of 442 studies reached it within 23 months; a quarter within 12 and three quarters within 46.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Australian and New Zealand Intensive Care Research Centre