Extracorporeal Membrane Oxygenation ComplicationECMO-RehabNCT05003609
Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation
A study testing Early Rehabilitation in people with Extracorporeal Membrane Oxygenation Complication, run by Australian and New Zealand Intensive Care Research Centre at 7 sites in 2 countries.
Trial summary
Critically ill patients who require extracorporeal membrane oxygenation (ECMO) are the sickest in the hospital. More patients are surviving but survivors have compromised functional recovery for months or years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Early Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 27 Apr 2022to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient is on ECMO and expected to remain on ECMO for at least 24 hours
- Patient is aged 18 years or older.
- Patient was functionally independent prior to the current admission.
- Patient is eligible for Medicare (Australian sites only).
Who cannot join
- Patient has been receiving ECMO for more than 72 hours.
- Patient has been in ICU for more than 5 days.
- Patient has suspected or proven primary myopathic or neurological process associated with prolonged weakness or acute brain injury.
- Death is deemed imminent by the treating clinician.
- Patient has a documented medical diagnosis of cognitive impairment e.g. dementia.
- Patient was unable to mobilise prior to this admission.
Show all 11Show fewer
- Patient is unable to communicate in local language.
- Patient is known to be pregnant.
- Patient is unlikely to be contactable for 6 months follow-up, e.g. overseas resident, incarcerated
- The treating clinician does not believe it is in the best interests of the patient to participate in the study
- Patient who has a bidirectional cannula in situ
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Australia6 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales
The Prince Charles Hospital
Chermside, Queensland, 4032
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Alfred Health
Melbourne, Victoria, 3004
Fiona Stanley Hospital
Murdoch, Western Australia
Princess Alexandra Hospital
Woolloongabba, Queensland
About this study
Official title: A Randomised Controlled Trial of Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)
Critically ill patients who require extracorporeal membrane oxygenation (ECMO) are the sickest in the hospital. More patients are surviving but survivors have compromised functional recovery for months or years. This registry-embedded randomised trial aims to determine if early rehabilitation commenced within 72 hours of ECMO is feasible and improves muscle strength and functional status in patients compared to standard practice in a randomised controlled trial of 100 ICU patients. The effect of the intervention on mortality, health status, and function at 180 days will be evaluated, as well as cost-effectiveness. ECMO-Rehab trial is a registry embedded trial and will be utilising EXCEL data.
Read the detailed description
The trial is a 100-patient, multicentre, randomised, controlled, parallel-group, two-sided superiority trial that will randomly allocate eligible patients to early rehabilitation or standard care in a 1:1 ratio to determine if early rehabilitation of critically ill patients receiving ECMO reduces disability when compared with standard care. ECMO-Rehab trial is a registry embedded trial and will be utilising EXCEL data.
- Being tested
- Early Rehabilitation
- Keywords
- Rehabilitation, ECMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early RehabilitationOther
The intervention involves a progression of rehabilitation exercises with the objective of rehabilitating the patient at the highest level of exercise possible for the patient for the longest period of time that can be tolerated (up to 60 mins) at each session. The intervention will be administered 5 days per week (weekdays) while the patient remains in ICU, censored at 28 days after randomisation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | ECMO early rehabilitation is led by a senior physiotherapist who has specialised training in ECMO care and coordinates individualised early physical training from randomisation to day 28 in ICU and liaises with the patient through to hospital discharge. The early rehabilitation intervention involves physical activity, functional retraining, strengthening exercises and mobilisation based on a reproducible, physiological approach. Receives: Other: Early Rehabilitation |
| Control Group | No intervention | The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
The Modified Rankin Scale (mRS) is a 7-level ordered categorical scale capturing levels of patient disability and dependence, with scores ranging from 0 (no disability) to 6 (dead).
Measured: 180 days post randomisation
Secondary outcomes (14)
Muscle strength at day 14 (Medical Research Council Sum-Score)
Grade 0 to Grade 5 where Grade 5 is the best outcome
Measured: 14 days post randomisation
ECMO-free days to day 28
Measured: 28 days post randomisation
Organ failure free days to day 28
Measured: 28 days post randomisation
Delirium-free days to day 28
Measured: 28 days post randomisation
Activities of Daily Living (ADL) at hospital discharge
Measured: up to day of hospital discharge, an average of 3 months
Length of stay on ECMO, in ICU and in hospital
Measured: up to day of stay on ECMO, ICU and hospital, an average of 3 months
Mortality rate at ICU and hospital discharge, day 90 and day 180
Measured: up to 180 days post randomisation
Instrumental activities of daily living at 180 days
Physical function measured with instrumental activities of daily living
Measured: 180 days post randomisation
Montreal Cognitive Assessment (MoCA-Blind)
Rapid screening instrument for mild cognitive dysfunction. Normal is equal or more than 18 points.
Measured: 180 days post randomisation
WHO Disability Assessment Schedule 2.0 at day 180
Scoring 10-48 are likely to have clinically significant disability.
Measured: 180 days post randomisation
Health related quality of life (EQ5D-5L) at day 180
Level of severity 1 to 5 where 5 is the most severe
Measured: 180 days post randomisation
Daily longitudinal ordinal organ support outcome to day 28
This includes outcomes on Dead; on ECMO; Off ECMO on IMV; Off IMV, in ICU; On acute hospital ward; Discharged alive
Measured: 28 days post randomisation
Healthcare costs at day 180
Index hospital admission costs will be determined using clinical costing systems at each participating site. Post discharge costs will be determined using patient-level data linkage to determine long-term health care use (including readmission to hospital).
Measured: 180 days post randomisation
Cost-effectiveness at day 180
The primary cost-effectiveness analysis will be conducted from the Australian healthcare payer's perspective using an analytical time horizon of 180 days.
Measured: 180 days post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start27 Apr 2022
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1;1 allocation, stratified by site,
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
- Investigators
- Carol Hodgson, Principal investigator, ANZIC-RC, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003609
- Sponsor's protocol ID
- ANZIC-RC/ECMO-REHAB/001
- Acronym
- ECMO-Rehab
- Status last verified
- Dec 2024
- First submitted
- 14 Jul 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ECMO-PT Study Investigators; International ECMO Network. Early mobilisation during extracorporeal membrane oxygenation was safe and feasible: a pilot randomised controlled trial. Intensive Care Med. 2020 May;46(5):1057-1059. doi: 10.1007/s00134-020-05994-8. Epub 2020 Mar 16. No abstract available.
PubMed 32179935
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)
- ClinicalTrials.gov ID
- NCT05003609
- Acronym / sponsor ID
- ECMO-Rehab / ANZIC-RC/ECMO-REHAB/001
- Keywords
- Rehabilitation, ECMO
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Monash University, National Health and Medical Research Council, Australia
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 12 Aug 2021 (actual)
- 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.
Critically ill patients who require extracorporeal membrane oxygenation (ECMO) are the sickest in the hospital. More patients are surviving but survivors have compromised functional recovery for months or years. This registry-embedded randomised trial aims to determine if early rehabilitation commenced within 72 hours of ECMO is feasible and improves muscle strength and functional status in patients compared to standard practice in a randomised controlled trial of 100 ICU patients. The effect of the intervention on mortality, health status, and function at 180 days will be evaluated, as well as cost-effectiveness. ECMO-Rehab trial is a registry embedded trial and will be utilising EXCEL data.
Detailed description
The trial is a 100-patient, multicentre, randomised, controlled, parallel-group, two-sided superiority trial that will randomly allocate eligible patients to early rehabilitation or standard care in a 1:1 ratio to determine if early rehabilitation of critically ill patients receiving ECMO reduces disability when compared with standard care. ECMO-Rehab trial is a registry embedded trial and will be utilising EXCEL data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1;1 allocation, stratified by site,
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Early RehabilitationECMO early rehabilitation is led by a senior physiotherapist who has specialised training in ECMO care and coordinates individualised early physical training from randomisation to day 28 in ICU and liaises with the patient through to hospital discharge. The early rehabilitation intervention involves physical activity, functional retraining, strengthening exercises and mobilisation based on a reproducible, physiological approach. |
| Control Group | No intervention | –The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is on ECMO and expected to remain on ECMO for at least 24 hours
- Patient is aged 18 years or older.
- Patient was functionally independent prior to the current admission.
- Patient is eligible for Medicare (Australian sites only).
Key exclusion criteria (11 listed)
- Patient has been receiving ECMO for more than 72 hours.
- Patient has been in ICU for more than 5 days.
- Patient has suspected or proven primary myopathic or neurological process associated with prolonged weakness or acute brain injury.
- Death is deemed imminent by the treating clinician.
- Patient has a documented medical diagnosis of cognitive impairment e.g. dementia.
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 |
|---|---|---|
| Early RehabilitationThe intervention involves a progression of rehabilitation exercises with the objective of rehabilitating the patient at the highest level of exercise possible for the patient for the longest period of time that can be tolerated (up to 60 mins) at each session. The intervention will be administered 5 days per week (weekdays) while the patient remains in ICU, censored at 28 days after randomisation. | Other | Intervention Group |
Primary outcome
Modified Rankin Scale
Time frame: 180 days post randomisation
The Modified Rankin Scale (mRS) is a 7-level ordered categorical scale capturing levels of patient disability and dependence, with scores ranging from 0 (no disability) to 6 (dead).
14 secondary outcomes
Muscle strength at day 14 (Medical Research Council Sum-Score)
Time frame: 14 days post randomisation
ECMO-free days to day 28
Time frame: 28 days post randomisation
Organ failure free days to day 28
Time frame: 28 days post randomisation
Delirium-free days to day 28
Time frame: 28 days post randomisation
Activities of Daily Living (ADL) at hospital discharge
Time frame: up to day of hospital discharge, an average of 3 months
Length of stay on ECMO, in ICU and in hospital
Time frame: up to day of stay on ECMO, ICU and hospital, an average of 3 months
Mortality rate at ICU and hospital discharge, day 90 and day 180
Time frame: up to 180 days post randomisation
Instrumental activities of daily living at 180 days
Time frame: 180 days post randomisation
Montreal Cognitive Assessment (MoCA-Blind)
Time frame: 180 days post randomisation
WHO Disability Assessment Schedule 2.0 at day 180
Time frame: 180 days post randomisation
Health related quality of life (EQ5D-5L) at day 180
Time frame: 180 days post randomisation
Daily longitudinal ordinal organ support outcome to day 28
Time frame: 28 days post randomisation
Healthcare costs at day 180
Time frame: 180 days post randomisation
Cost-effectiveness at day 180
Time frame: 180 days post randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 32179935ECMO-PT Study Investigators; International ECMO Network. Early mobilisation during extracorporeal membrane oxygenation was safe and feasible: a pilot randomised controlled trial. Intensive Care Med. 2020 May;46(5):1057-1059. doi: 10.1007/s00134-020-05994-8. Epub 2020 Mar 16. No abstract available.
- 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.
Carol Hodgson principal investigator
ANZIC-RC, Monash University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Rehabilitation in people with Extracorporeal Membrane Oxygenation Complication, run by Australian and New Zealand Intensive Care Research Centre at 7 sites in 2 countries.
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 4 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Modified Rankin Scale (time frame: 180 days post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05003609, which also lists 1 linked publication.
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 10 Dec 2024.