Critical IllnessNCT03026985
Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring ECMO
An observational study of Critical Illness and Muscle Wasting, run by The Alfred at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Muscle Wasting, Extracorporeal Membrane Oxygenation
- What is being tested?
- Observational cohort
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Jan 2017to 19 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients admitted to the ICU requiring ECMO
Who may be able to join
- Adult patients (≥18 years)
- Requiring ECMO for management of severe cardiac or respiratory failure
- Likely to spend > 24 hours on ECMO
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring Extracorporeal Membrane Oxygenation (ECMO)
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.
Read the detailed description
The use of ECMO has increased dramatically in the past decade with improvements in technology and survival. Whilst it is a potentially life-saving intervention in a group of patients at high risk of death, it is both highly invasive and expensive. ECMO poses a dramatic physiological burden on patients with major long-term consequences. Among these, severe prolonged neuromuscular weakness is perhaps the most significant complication. Described clinically as intensive care unit acquired weakness (ICUAW), it is associated with prolonged weaning from mechanical ventilation, delayed rehabilitation, increased hospital length of stay, and mortality with residual deficits in physical functional ability persisting up to 5 years following the ICU admission. The health value, to both patients and society, could be substantially improved if more patients achieved a complete recovery.
Muscle strength testing in the early stages of critical illness is limited, as it requires the patient to be awake, alert and cognitively intact, therefore delayed diagnosis of ICUAW due to inability of patients to complete muscle strength testing is common. Consequently, there is growing interest in the utility of ultrasound imaging to monitor the trajectory of muscle wasting and inform development of targeted interventions in these critically ill patients. Ultrasound imaging of skeletal muscle is a non-invasive, painless and radiation free technique that can provide objective, accurate and reliable data on skeletal muscle in these critically ill patients. This study will use ultrasound imaging to quantify the early change in skeletal muscle size and quality, and the relationship to strength and physical function in patients on ECMO. Risk stratification of patients with peripheral muscle wasting is vital for optimising clinical management, including development of improved rehabilitative strategies to improve recovery and optimise the risk/benefit profile of ECMO.
- Being tested
- Observational cohort
- Keywords
- Extracorporeal Membrane Oxygenation, Ultrasonography, Intensive Care Units
- Medical subject headings
- Critical Illness, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational cohortOther
Ultrasound assessment of quadriceps, muscle strength testing, highest mobility level
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quadriceps muscle size as determined by ultrasound in patients requiring ECMO
Change in quadriceps muscle size
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start25 Jan 2017
- Primary completion19 Sep 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Hayes, The Alfred
- Investigators
- Kate Hayes, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026985
- Sponsor's protocol ID
- 516/16
- Status last verified
- Sep 2017
- First submitted
- 15 Jan 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring Extracorporeal Membrane Oxygenation (ECMO)
- ClinicalTrials.gov ID
- NCT03026985
- Acronym / sponsor ID
- 516/16
- Keywords
- Extracorporeal Membrane Oxygenation, Ultrasonography, Intensive Care Units
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The use of ECMO has increased dramatically in the past decade with improvements in technology and survival. Whilst it is a potentially life-saving intervention in a group of patients at high risk of death, it is both highly invasive and expensive. ECMO poses a dramatic physiological burden on patients with major long-term consequences. Among these, severe prolonged neuromuscular weakness is perhaps the most significant complication. Described clinically as intensive care unit acquired weakness (ICUAW), it is associated with prolonged weaning from mechanical ventilation, delayed rehabilitation, increased hospital length of stay, and mortality with residual deficits in physical functional ability persisting up to 5 years following the ICU admission. The health value, to both patients and society, could be substantially improved if more patients achieved a complete recovery.
Muscle strength testing in the early stages of critical illness is limited, as it requires the patient to be awake, alert and cognitively intact, therefore delayed diagnosis of ICUAW due to inability of patients to complete muscle strength testing is common. Consequently, there is growing interest in the utility of ultrasound imaging to monitor the trajectory of muscle wasting and inform development of targeted interventions in these critically ill patients. Ultrasound imaging of skeletal muscle is a non-invasive, painless and radiation free technique that can provide objective, accurate and reliable data on skeletal muscle in these critically ill patients. This study will use ultrasound imaging to quantify the early change in skeletal muscle size and quality, and the relationship to strength and physical function in patients on ECMO. Risk stratification of patients with peripheral muscle wasting is vital for optimising clinical management, including development of improved rehabilitative strategies to improve recovery and optimise the risk/benefit profile of ECMO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | Other: Observational cohortUltrasound 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted to the ICU requiring ECMO
Key inclusion criteria (3 listed)
- Adult patients (≥18 years)
- Requiring ECMO for management of severe cardiac or respiratory failure
- Likely to spend > 24 hours on ECMO
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational cohortUltrasound assessment of quadriceps, muscle strength testing, highest mobility level | Other | Observational cohort |
Primary outcome
Change in quadriceps muscle size as determined by ultrasound in patients requiring ECMO
Time frame: 10 days
Change in quadriceps muscle size
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Hayes principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Muscle Wasting, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quadriceps muscle size as determined by ultrasound in patients requiring ECMO (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.