- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04896515
INTENT-Muscle (A Sub-study of INTENT)
Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial - Muscle (a Sub-study of INTENT)
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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)
- 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)
- Compare clinical and functional outcomes in patients identified as having low muscularity (assessed by ultrasound) at ICU admission
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- Blacktown Hospital
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Kingswood, New South Wales, Australia, 2747
- Nepean Hospital
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Victoria
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Ballarat, Victoria, Australia, 3353
- Ballarat Base Hospital
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Frankston, Victoria, Australia, 3199
- Frankston Hospital
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
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Auckland, New Zealand, 1023
- Auckland Hospital (CVICU)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
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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. |
Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase angle
Time Frame: Hospital admission (censored at study day 28)
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To compare longitudinal changes in phase angle during hospital admission in patients randomised to both arms of INTENT.
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Hospital admission (censored at study day 28)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bioelectrical impedance spectroscopy (BIS) derived phase angle
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived phase angle from baseline to hospital discharge and every 7 days between
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Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived impedance ratio
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived impedance ratio from baseline to hospital discharge and every 7 days between.
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Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived fat-free mass
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived fat-free mass (kg) from baseline to hospital discharge and every 7 days between.
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Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived normally-hydrated lean tissue
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived normally-hydrated lean tissue (kg) (generated using the Chamney model) from baseline to hospital discharge and every 7 days between.
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Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived Cole model variable R infinity to R0
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived Cole model variable R infinity to R0 from baseline to hospital discharge and every 7 days between.
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Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived characteristic frequency (ωc, a Cole model variable)
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived Cole model variable characteristic frequency (ωc) from baseline to hospital discharge and every 7 days between.
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Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived membrane capacitance (a Cole model variable)
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived Cole model variable membrane capacitance from baseline to hospital discharge and every 7 days between.
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Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived extra-cellular water
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived extracellular water from baseline to hospital discharge and every 7 days between.
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Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived intracellular water
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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Change in BIS-derived intracellular water from baseline to hospital discharge and every 7 days between.
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Every 7 days during hospital admission (censored to study day 28)
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Change in ultrasound-derived Rectus femoris cross-sectional area
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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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).
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Every 7 days during hospital admission (censored to study day 28)
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Change in ultrasound-derived mid-upper arm muscle thickness
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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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).
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Every 7 days during hospital admission (censored to study day 28)
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Change in ultrasound-derived bilateral quadriceps muscle thickness
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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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).
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Every 7 days during hospital admission (censored to study day 28)
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Change in ultrasound-derived Rectus femoris echogenicity
Time Frame: Every 7 days during hospital admission (censored to study day 28)
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Change in ultrasound-derived Rectus femoris echogenicity from baseline to hospital discharge and at measurement points (every 7 days during hospital admission).
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Every 7 days during hospital admission (censored to study day 28)
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Muscle mass at ICU admission
Time Frame: Baseline (Enrolment)
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An estimate of whole-body muscularity at ICU admission (enrolment) will be assessed by ultrasound
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Baseline (Enrolment)
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Collaborators and Investigators
Investigators
- Principal Investigator: Emma J Ridley, PhD, Australian and New Zealand Intensive Care Research Centre
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANZIC-RC/ER003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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