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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03026985
Ethics application status
Date submitted
15/01/2017
Date registered
20/01/2017
Date last updated
26/09/2017

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
516/16
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

Intervention/exposure
Study type
Observational
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

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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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 asphyxiation
* 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 inevitable

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/09/2017
Sample size
Target
Accrual to date
Final
25
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
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/study/NCT03026985
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03026985