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Muscle mass and functional outcomes in critically Ill patients receiving augmented enteral protein – The MAINTAIN study

Muscle mass and functional outcomes in critically Ill patients receiving augmented enteral protein – The MAINTAIN study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001465741
Acronym
The MAINTAIN study
Enrollment
72
Registered
2022-11-18
Start date
2022-11-25
Completion date
2023-05-24
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients admitted to the Intensive Care Unit (ICU) are the most acutely unwell in hospital, and those that survive experience significant muscle wasting and poor functional outcomes. Nutrition therapy, usually delivered to ICU patients as liquid formula via a tube into the stomach, has the potential to improve at least part of the significant muscle atrophy that occurs, and hence enhance functional recovery from critical illness. Current international guidelines recommend delivery of protein doses of 1.2 - 2.0 g/kg bodyweight/day or higher, but this is based on very low quality of evidence. It has been reported in observational studies that a large proportion of ICU patients do not meet these prescribed protein targets. The TARGET Protein study is a large randomised controlled trial comparing augmented protein doses recommended in international guidelines to current standard care (ACTRN12621001484831). Augmenting dietary protein has the capability to achieve these recommended protein targets, yet it is unknown whether meeting protein targets improves muscle mass or functional outcomes following critical illness. We propose undertaking a prospective sub-study within a large randomised controlled trial to measure muscle mass, strength and physical function in critically ill patients receiving high protein protein doses compared to standard care.

Interventions

Sponsors

Central Adelaide Local Health Network
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients admitted to ICU and commence enteral nutrition

Exclusion criteria

Expected to require <48 hrs of enteral nutrition in ICU Bilateral quadriceps not accessible and unable to complete study measure e.g. burns, femoral shaft fractures, above knee amputations, prone ventilated Pregnant Unable to complete baseline measurement within 48h of enteral nutrition commencement Expected death, or expected palliative care prior to day 7

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026