INTENT-Muscle (A Sub-study of INTENT)

NCT ID: NCT04896515

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2023-02-27

Brief 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 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:

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.

Conditions

Critically Ill

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

Supplemental parenteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)

Interventions

Supplemental parenteral nutrition

Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Australian and New Zealand Intensive Care Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma J Ridley, PhD

Role: PRINCIPAL_INVESTIGATOR

Australian and New Zealand Intensive Care Research Centre

Locations

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

The Alfred Hospital

Melbourne, Victoria, Australia

Auckland Hospital (CVICU)

Auckland, , New Zealand

Countries

Australia; New Zealand

Other Identifiers

ANZIC-RC/ER003

Identifier Type: -

Identifier Source: org_study_id