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Completed

NCT Number: NCT04896515

INTENT-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.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Blacktown Hospital, Blacktown, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Supplemental parenteral nutrition

Dietary Supplement

Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 phase angle from baseline to hospital discharge and every 7 days between

  2. Change in BIS-derived impedance ratio

    Time frame: Every 7 days during hospital admission (censored to study day 28)

    Change in BIS-derived impedance ratio from baseline to hospital discharge and every 7 days between.

  3. Change in BIS-derived fat-free mass

    Time frame: Every 7 days during hospital admission (censored to study day 28)

    Change in BIS-derived fat-free mass (kg) from baseline to hospital discharge and every 7 days between.

  4. 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 normally-hydrated lean tissue (kg) (generated using the Chamney model) from baseline to hospital discharge and every 7 days between.

  5. 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 Cole model variable R infinity to R0 from baseline to hospital discharge and every 7 days between.

  6. 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 Cole model variable characteristic frequency (ωc) from baseline to hospital discharge and every 7 days between.

  7. 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 Cole model variable membrane capacitance from baseline to hospital discharge and every 7 days between.

  8. Change in BIS-derived extra-cellular water

    Time frame: Every 7 days during hospital admission (censored to study day 28)

    Change in BIS-derived extracellular water from baseline to hospital discharge and every 7 days between.

  9. Change in BIS-derived intracellular water

    Time frame: Every 7 days during hospital admission (censored to study day 28)

    Change in BIS-derived intracellular water from baseline to hospital discharge and every 7 days between.

  10. 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 Rectus femoris cross-sectional area (cm2) from baseline to hospital discharge and at measurement points (every 7 days during hospital admission).

  11. 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 muscle thickness (in centimetres) at the mid-upper arm from baseline to hospital discharge and at measurement points (every 7 days during hospital admission).

  12. 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 bilateral quadriceps muscle thickness (in centimetres) from baseline to hospital discharge and at measurement points (every 7 days during hospital admission).

  13. Change in ultrasound-derived Rectus femoris echogenicity

    Time frame: Every 7 days during hospital admission (censored to study day 28)

    Change in ultrasound-derived Rectus femoris echogenicity from baseline to hospital discharge and at measurement points (every 7 days during hospital admission).

  14. Muscle mass at ICU admission

    Time frame: Baseline (Enrolment)

    An estimate of whole-body muscularity at ICU admission (enrolment) will be assessed by ultrasound

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Registry information

Official study title

Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial - Muscle (a Sub-study of INTENT)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 21, 2021
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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