INTENT-Muscle (A Sub-study of INTENT)

NCT04896515 | Completed

• 1 other identifier: ANZIC-RC/ER003
• Study Type: observational
• Target: 21
• Locations: 2 countries
• Sites: 6

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.

Conditions

Critically Ill

Keywords

Critically ill; Critical illness; Muscle; Nutrition; Intensive care unit; Ward; Ultrasound; Adult

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (14)

• Change in bioelectrical impedance spectroscopy (BIS) derived phase angle

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

• Change in BIS-derived impedance ratio

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

• Change in BIS-derived fat-free mass

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

• Change in BIS-derived normally-hydrated lean tissue

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

• Change in BIS-derived Cole model variable R infinity to R0

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

Study Arms (2)

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.

Dietary Supplement: Supplemental parenteral nutrition

Interventions

Supplemental parenteral nutrition DIETARY_SUPPLEMENT

Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)

Intensive Nutrition Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Randomised to the INTENT trial at a participating sub-study site

You may not qualify if:

• 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)

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead

Study Sites (6)

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

Ballarat Base Hospital

Ballarat, Victoria, 3353, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Auckland Hospital (CVICU)

Auckland, 1023, New Zealand

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emma J Ridley, PhD

  Australian and New Zealand Intensive Care Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: May 21, 2021
• Study Start: June 21, 2021
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

NZ (1); AU (5)