Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— ECMO-Rehab  

Official title:

A Randomised Controlled Trial of Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003609
• Other study ID #: ANZIC-RC/ECMO-REHAB/001
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2022
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: Carol Hodgson
• Phone: +61 448 674 532
• Email: carol.hodgson[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Alfred Health	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	Monash University, National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events	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
Primary	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).	180 days post randomisation
Secondary	Muscle strength at day 14 (Medical Research Council Sum-Score)	Grade 0 to Grade 5 where Grade 5 is the best outcome	14 days post randomisation
Secondary	ECMO-free days to day 28		28 days post randomisation
Secondary	Organ failure free days to day 28		28 days post randomisation
Secondary	Delirium-free days to day 28		28 days post randomisation
Secondary	Activities of Daily Living (ADL) at hospital discharge		up to day of hospital discharge, an average of 3 months
Secondary	Length of stay on ECMO, in ICU and in hospital		up to day of stay on ECMO, ICU and hospital, an average of 3 months
Secondary	Mortality rate at ICU and hospital discharge, day 90 and day 180		up to 180 days post randomisation
Secondary	Instrumental activities of daily living at 180 days	Physical function measured with instrumental activities of daily living	180 days post randomisation
Secondary	Montreal Cognitive Assessment (MoCA-Blind)	Rapid screening instrument for mild cognitive dysfunction. Normal is equal or more than 18 points.	180 days post randomisation
Secondary	WHO Disability Assessment Schedule 2.0 at day 180	Scoring 10-48 are likely to have clinically significant disability.	180 days post randomisation
Secondary	Health related quality of life (EQ5D-5L) at day 180	Level of severity 1 to 5 where 5 is the most severe	180 days post randomisation