Clinical trial NCT04896515: INTENT-Muscle (A Sub-study of INTENT)
Official title: Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial - Muscle (a Sub-study of INTENT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: Critically ill
Critical illness
Muscle
Nutrition
Intensive care unit
Ward
Ultrasound
Adult
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sixty to eighty critically ill patients from up to 6 participating INTENT sites in Australia and New Zealand will be recruited to INTENT-Muscle

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.

Detailed description: 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:

1. Compare longitudinal changes in bioimpedance variables (fat-free mass, normally hydrated lean tissue, extracellular/intracellular ratio, and variables from Cole modelling) to hospital discharge (or day 28)
2. Compare longitudinal changes in ultrasound variables (mid-upper arm and quadriceps muscle thickness, rectus femoris cross-sectional area, and rectus femoris echogenicity) to hospital discharge (or day 28)
3. Compare clinical and functional outcomes in patients identified as having low muscularity (assessed by ultrasound) at ICU admission
4. Investigate the relationship between bioimpedance and ultrasound variables with clinical and functional outcomes at baseline and over the hospital admission (collected as part of INTENT)

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.

Eligibility criteria: Inclusion Criteria:

* Randomised to the INTENT trial at a participating sub-study site

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)

Primary outcomes:
measure: Phase angle
timeFrame: Hospital admission (censored at study day 28)
Secondary outcomes:
measure: Change in bioelectrical impedance spectroscopy (BIS) derived phase angle
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in BIS-derived impedance ratio
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in BIS-derived fat-free mass
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in BIS-derived normally-hydrated lean tissue
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in BIS-derived Cole model variable R infinity to R0
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in BIS-derived characteristic frequency (ωc, a Cole model variable)
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in BIS-derived membrane capacitance (a Cole model variable)
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in BIS-derived extra-cellular water
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in BIS-derived intracellular water
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in ultrasound-derived Rectus femoris cross-sectional area
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in ultrasound-derived mid-upper arm muscle thickness
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in ultrasound-derived bilateral quadriceps muscle thickness
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Change in ultrasound-derived Rectus femoris echogenicity
timeFrame: Every 7 days during hospital admission (censored to study day 28)
measure: Muscle mass at ICU admission
timeFrame: Baseline (Enrolment)
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Auckland
country: New Zealand
facility: Auckland Hospital (CVICU)
Study officials:
affiliation: Australian and New Zealand Intensive Care Research Centre
name: Emma J Ridley, PhD
role: PRINCIPAL_INVESTIGATOR
References: