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: 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.
Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
Blacktown Hospital
Blacktown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Ballarat Base Hospital
Ballarat, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
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)
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Study Type
OBSERVATIONAL
Enrollment
21
The Alfred Hospital
Melbourne, Victoria, Australia
Auckland Hospital (CVICU)
Auckland, New Zealand
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)