- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05003609
Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)
December 5, 2022 updated by: Australian and New Zealand Intensive Care Research Centre
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carol Hodgson
- Phone Number: +61 448 674 532
- Email: carol.hodgson@monash.edu
Study Contact Backup
- Name: Nicole Ng
- Phone Number: +61 03 9903 0391
- Email: nicole.ng@monash.edu
Study Locations
-
-
New South Wales
-
Darlinghurst, New South Wales, Australia, 2010
- Recruiting
- St Vincent'S Hospital Sydney
-
Contact:
- George Ntoumenopoulos
- Email: george.ntoumenopoulos@svha.org.au
-
-
Queensland
-
Chermside, Queensland, Australia, 4032
- Recruiting
- The Prince Charles Hospital
-
Contact:
- Oystein Tronstad
- Email: oystein.tronstad@health.qld.gov.au
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Recruiting
- Alfred Health
-
Contact:
- Annie Jones
- Email: an.jones@alfred.org.au
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
No Intervention: Control Group
The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
180 days post randomisation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength at day 14 (Medical Research Council Sum-Score)
Time Frame: 14 days post randomisation
|
Grade 0 to Grade 5 where Grade 5 is the best outcome
|
14 days post randomisation
|
ECMO-free days to day 28
Time Frame: 28 days post randomisation
|
28 days post randomisation
|
|
Organ failure free days to day 28
Time Frame: 28 days post randomisation
|
28 days post randomisation
|
|
Delirium-free days to day 28
Time Frame: 28 days post randomisation
|
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
|
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
|
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
|
up to 180 days post randomisation
|
|
Instrumental activities of daily living at 180 days
Time Frame: 180 days post randomisation
|
Physical function measured with instrumental activities of daily living
|
180 days post randomisation
|
Montreal Cognitive Assessment (MoCA-Blind)
Time Frame: 180 days post randomisation
|
Rapid screening instrument for mild cognitive dysfunction.
Normal is equal or more than 18 points.
|
180 days post randomisation
|
WHO Disability Assessment Schedule 2.0 at day 180
Time Frame: 180 days post randomisation
|
Scoring 10-48 are likely to have clinically significant disability.
|
180 days post randomisation
|
Health related quality of life (EQ5D-5L) at day 180
Time Frame: 180 days post randomisation
|
Level of severity 1 to 5 where 5 is the most severe
|
180 days post randomisation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Up to 28 days post randomisation
|
Number of patients who suffered adverse events such as fall, heart attack or new or increased oozing around cannulae during rehabilitation.
|
Up to 28 days post randomisation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carol Hodgson, ANZIC-RC, Monash University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 27, 2022
Primary Completion (Anticipated)
May 31, 2024
Study Completion (Anticipated)
May 31, 2024
Study Registration Dates
First Submitted
July 14, 2021
First Submitted That Met QC Criteria
August 3, 2021
First Posted (Actual)
August 12, 2021
Study Record Updates
Last Update Posted (Estimate)
December 7, 2022
Last Update Submitted That Met QC Criteria
December 5, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ANZIC-RC/ECMO-REHAB/001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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