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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03026985

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring ECMO
Scientific title
Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring Extracorporeal Membrane Oxygenation (ECMO)
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Muscle Wasting 0 0
Extracorporeal Membrane Oxygenation 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Observational cohort

Observational cohort - Ultrasound measurement of quadriceps muscle size and echogenicity will be obtained at baseline (within 48 hours of ECMO commencement), 10 days and 20 days after baseline measurement.
Measures of muscle strength and highest mobility level will be obtained at day 10 and day 20 after baseline measurement in order to determine the relationship between these volitional measures and the ultrasound parameters.

Other interventions: Observational cohort
Ultrasound assessment of quadriceps, muscle strength testing, highest mobility level

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Change in quadriceps muscle size as determined by ultrasound in patients requiring ECMO - Change in quadriceps muscle size
Timepoint [1] 0 0
10 days

Key inclusion criteria
- Adult patients (=18 years)

- Requiring ECMO for management of severe cardiac or respiratory failure

- Likely to spend > 24 hours on ECMO
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Presence of:

- Any connective tissue disorders (e.g., Marfan's syndrome)

- A proven or suspected acute primary brain process that is likely to result in global
impairment of conscious level or cognition, such as traumatic brain injury,
intracranial haemorrhage, stroke, or hypoxic brain injury after cardiac arrest or

- Any neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal
cord injury, Guillain-Barre syndrome)

- Any current cancer or chemotherapy

- A cognitive impairment prior to the acute illness that is associated with admission to
ICU that would impair capacity to follow verbal instructions Any current acute
musculoskeletal injuries of hip, knee, and ankle

- A pre-existing mobility impairment where the patient is unable to walk without
assistance prior to the acute illness that is associated with admission to ICU (use of
a walking stick or frame is not an exclusion)

- A language barrier to patient comprehension, or where death is deemed imminent and

Study design
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
The Alfred

Ethics approval
Ethics application status

Brief summary
The purpose of this study is to describe the changes in quadriceps muscle size and quality
over the first 10 days on extracorporeal membrane oxygenation (ECMO) using ultrasound
imaging. This study will also examine the relationship between those changes and muscle
strength and level of physical function at day 10 and day 20 after ECMO commencement.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Kate Hayes
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications