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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05003609




Registration number
NCT05003609
Ethics application status
Date submitted
14/07/2021
Date registered
12/08/2021
Date last updated
7/12/2022

Titles & IDs
Public title
Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation
Scientific title
A Randomised Controlled Trial of Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)
Secondary ID [1] 0 0
ANZIC-RC/ECMO-REHAB/001
Universal Trial Number (UTN)
Trial acronym
ECMO-Rehab
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extracorporeal Membrane Oxygenation Complication 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Early Rehabilitation

Active Comparator: Intervention Group - 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.

No Intervention: Control Group - The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation.


Other interventions: Early Rehabilitation
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Rankin Scale
Timepoint [1] 0 0
180 days post randomisation
Secondary outcome [1] 0 0
Muscle strength at day 14 (Medical Research Council Sum-Score)
Timepoint [1] 0 0
14 days post randomisation
Secondary outcome [2] 0 0
ECMO-free days to day 28
Timepoint [2] 0 0
28 days post randomisation
Secondary outcome [3] 0 0
Organ failure free days to day 28
Timepoint [3] 0 0
28 days post randomisation
Secondary outcome [4] 0 0
Delirium-free days to day 28
Timepoint [4] 0 0
28 days post randomisation
Secondary outcome [5] 0 0
Activities of Daily Living (ADL) at hospital discharge
Timepoint [5] 0 0
up to day of hospital discharge, an average of 3 months
Secondary outcome [6] 0 0
Length of stay on ECMO, in ICU and in hospital
Timepoint [6] 0 0
up to day of stay on ECMO, ICU and hospital, an average of 3 months
Secondary outcome [7] 0 0
Mortality rate at ICU and hospital discharge, day 90 and day 180
Timepoint [7] 0 0
up to 180 days post randomisation
Secondary outcome [8] 0 0
Instrumental activities of daily living at 180 days
Timepoint [8] 0 0
180 days post randomisation
Secondary outcome [9] 0 0
Montreal Cognitive Assessment (MoCA-Blind)
Timepoint [9] 0 0
180 days post randomisation
Secondary outcome [10] 0 0
WHO Disability Assessment Schedule 2.0 at day 180
Timepoint [10] 0 0
180 days post randomisation
Secondary outcome [11] 0 0
Health related quality of life (EQ5D-5L) at day 180
Timepoint [11] 0 0
180 days post randomisation

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05003609
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Carol Hodgson
Address 0 0
ANZIC-RC, Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carol Hodgson
Address 0 0
Country 0 0
Phone 0 0
+61 448 674 532
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05003609