Status:
COMPLETED
INTENT-Muscle (A Sub-study of INTENT)
Lead Sponsor:
Australian and New Zealand Intensive Care Research Centre
Conditions:
Critically Ill
Eligibility:
All Genders
18+ years
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 i...
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 kn...
Eligibility Criteria
Inclusion
- Randomised to the INTENT trial at a participating sub-study site
Exclusion
- 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)
Key Trial Info
Start Date :
June 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 27 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04896515
Start Date
June 21 2021
End Date
February 27 2023
Last Update
May 24 2024
Active Locations (6)
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1
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
2
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
3
Ballarat Base Hospital
Ballarat, Victoria, Australia, 3353
4
Frankston Hospital
Frankston, Victoria, Australia, 3199