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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
After ICU: 1. Nutrition management will be as per usual site management at that hospital. | ||
| Intensive Nutrition Arm | In ICU:
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemental parenteral nutrition | Dietary Supplement | Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase angle | To compare longitudinal changes in phase angle during hospital admission in patients randomised to both arms of INTENT. | Hospital admission (censored at study day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Every 7 days during hospital admission (censored to study day 28) |
| Change in BIS-derived impedance ratio |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from the sub-study if they have any of the following:
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Sixty to eighty critically ill patients from up to 6 participating INTENT sites in Australia and New Zealand will be recruited to INTENT-Muscle
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| Name | Affiliation | Role |
|---|---|---|
| Emma J Ridley, PhD | Australian and New Zealand Intensive Care Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blacktown Hospital | Blacktown | New South Wales | 2148 | Australia | ||
| Nepean Hospital |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Change in BIS-derived impedance ratio from baseline to hospital discharge and every 7 days between. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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 | Baseline (Enrolment) |
| Kingswood |
| New South Wales |
| 2747 |
| Australia |
| Ballarat Base Hospital | Ballarat | Victoria | 3353 | Australia |
| Frankston Hospital | Frankston | Victoria | 3199 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Auckland Hospital (CVICU) | Auckland | 1023 | New Zealand |