Critically IllNCT04896515
INTENT-Muscle (A Sub-study of INTENT)
An observational study of Critically Ill, run by Australian and New Zealand Intensive Care Research Centre at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Supplemental parenteral nutrition
- How many people
- 21 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 21 Jun 2021to 27 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Randomised to the INTENT trial at a participating sub-study site
Who cannot join
- 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)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia5 sites
Ballarat Base Hospital
Ballarat, Victoria, 3353
Blacktown Hospital
Blacktown, New South Wales, 2148
Frankston Hospital
Frankston, Victoria, 3199
Nepean Hospital
Kingswood, New South Wales, 2747
The Alfred Hospital
Melbourne, Victoria, 3004
About this study
Official title: Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial - Muscle (a Sub-study of INTENT)
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.
Read the 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.
- Conditions
- Critically Ill
- Being tested
- Supplemental parenteral nutrition
- Keywords
- Critically ill, Critical illness, Muscle, Nutrition, Intensive care unit, Ward, Ultrasound, Adult
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental parenteral nutritionDietary supplement
Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
| Study group | Role | What they receive |
|---|---|---|
| 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: 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. | |
| Intensive Nutrition Arm | 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. Receives: Dietary Supplement: Supplemental parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase angle
To compare longitudinal changes in phase angle during hospital admission in patients randomised to both arms of INTENT.
Measured: Hospital admission (censored at study day 28)
Secondary outcomes (14)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: Baseline (Enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start21 Jun 2021
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma J Ridley, PhD, Principal investigator, Australian and New Zealand Intensive Care Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896515
- Sponsor's protocol ID
- ANZIC-RC/ER003
- Status last verified
- May 2024
- First submitted
- 15 Apr 2021
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial - Muscle (a Sub-study of INTENT)
- ClinicalTrials.gov ID
- NCT04896515
- Acronym / sponsor ID
- ANZIC-RC/ER003
- Conditions
- Critically Ill
- Keywords
- Critically ill, Critical illness, Muscle, Nutrition, Intensive care unit, Ward, Ultrasound, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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: 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. |
| Intensive Nutrition Arm | – | Dietary Supplement: Supplemental parenteral nutritionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Randomised to the INTENT trial at a participating sub-study site
Key exclusion criteria (8 listed)
- Patients will be excluded from the sub-study if they have any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplemental parenteral nutritionSupplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation) | Dietary supplement | Intensive Nutrition Arm |
Primary outcome
Phase angle
Time frame: Hospital admission (censored at study day 28)
To compare longitudinal changes in phase angle during hospital admission in patients randomised to both arms of INTENT.
14 secondary outcomes
Change in bioelectrical impedance spectroscopy (BIS) derived phase angle
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived impedance ratio
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived fat-free mass
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived normally-hydrated lean tissue
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived Cole model variable R infinity to R0
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived characteristic frequency (ωc, a Cole model variable)
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived membrane capacitance (a Cole model variable)
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived extra-cellular water
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in BIS-derived intracellular water
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in ultrasound-derived Rectus femoris cross-sectional area
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in ultrasound-derived mid-upper arm muscle thickness
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in ultrasound-derived bilateral quadriceps muscle thickness
Time frame: Every 7 days during hospital admission (censored to study day 28)
Change in ultrasound-derived Rectus femoris echogenicity
Time frame: Every 7 days during hospital admission (censored to study day 28)
Muscle mass at ICU admission
Time frame: Baseline (Enrolment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma J Ridley, PhD principal investigator
Australian and New Zealand Intensive Care Research Centre
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Australian and New Zealand Intensive Care Research Centre at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase angle (time frame: Hospital admission (censored at study day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.