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

Not Applicable

Completed

• Conditions: Critical Illness; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12622001465741
• Lead Sponsor: Central Adelaide Local Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-18
• Study Completion: 2023-08-23
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in ultrasound-derived quadricep muscle layer thickness (QMLT)[ Assessed within 48 hours of commencement of enteral nutrition and at day 7 post-commencement of enteral nutrition]

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed using the EuroQol five dimension five-level (EQ-5D-5L)[ Day 90 post commencement of enteral nutrition ];Change in functional status assessed using the Barthel Index[ ICU discharge];Muscle strength assessed using a hand grip dynamometer[ ICU dischagre];Rate of ICU-acquired weakness, as defined by a score of less than 48 on the Medical Research Council Sum Score[ ICU discharge];Physical function assessed using the World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 questionnaire[ Day 90 post commencement of enteral nutrition]