Clinical trial NCT05003609: Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation
Official title: A Randomised Controlled Trial of Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation Complication
Keywords: Rehabilitation
ECMO
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: Monash University
name: National Health and Medical Research Council, Australia
First posted: 2021-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1;1 allocation, stratified by site,
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patient is on ECMO and expected to remain on ECMO for at least 24 hours
2. Patient is aged 18 years or older.
3. Patient was functionally independent prior to the current admission.
4. Patient is eligible for Medicare (Australian sites only).

Exclusion Criteria:

1. Patient has been receiving ECMO for more than 72 hours.
2. Patient has been in ICU for more than 5 days.
3. Patient has suspected or proven primary myopathic or neurological process associated with prolonged weakness or acute brain injury.
4. Death is deemed imminent by the treating clinician.
5. Patient has a documented medical diagnosis of cognitive impairment e.g. dementia.
6. Patient was unable to mobilise prior to this admission.
7. Patient is unable to communicate in local language.
8. Patient is known to be pregnant.
9. Patient is unlikely to be contactable for 6 months follow-up, e.g. overseas resident, incarcerated
10. The treating clinician does not believe it is in the best interests of the patient to participate in the study
11. Patient who has a bidirectional cannula in situ

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 180 days post randomisation
Secondary outcomes:
measure: Muscle strength at day 14 (Medical Research Council Sum-Score)
timeFrame: 14 days post randomisation
measure: ECMO-free days to day 28
timeFrame: 28 days post randomisation
measure: Organ failure free days to day 28
timeFrame: 28 days post randomisation
measure: Delirium-free days to day 28
timeFrame: 28 days post randomisation
measure: Activities of Daily Living (ADL) at hospital discharge
timeFrame: up to day of hospital discharge, an average of 3 months
measure: Length of stay on ECMO, in ICU and in hospital
timeFrame: up to day of stay on ECMO, ICU and hospital, an average of 3 months
measure: Mortality rate at ICU and hospital discharge, day 90 and day 180
timeFrame: up to 180 days post randomisation
measure: Instrumental activities of daily living at 180 days
timeFrame: 180 days post randomisation
measure: Montreal Cognitive Assessment (MoCA-Blind)
timeFrame: 180 days post randomisation
measure: WHO Disability Assessment Schedule 2.0 at day 180
timeFrame: 180 days post randomisation
measure: Health related quality of life (EQ5D-5L) at day 180
timeFrame: 180 days post randomisation
measure: Daily longitudinal ordinal organ support outcome to day 28
timeFrame: 28 days post randomisation
measure: Healthcare costs at day 180
timeFrame: 180 days post randomisation
measure: Cost-effectiveness at day 180
timeFrame: 180 days post randomisation
Other outcomes:
measure: Incidence of adverse events
timeFrame: Up to 28 days post randomisation
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Toronto
country: Canada
facility: Toronto General Hospital
Study officials:
affiliation: ANZIC-RC, Monash University
name: Carol Hodgson
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.