Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05003609

Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Extracorporeal Membrane Oxygenation Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early rehabilitation

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. ECMO-free days to day 28

    Time frame: 28 days post randomisation

  3. Organ failure free days to day 28

    Time frame: 28 days post randomisation

  4. Delirium-free days to day 28

    Time frame: 28 days post randomisation

  5. Activities of Daily Living (ADL) at hospital discharge

    Time frame: up to day of hospital discharge, an average of 3 months

  6. 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

  7. Mortality rate at ICU and hospital discharge, day 90 and day 180

    Time frame: up to 180 days post randomisation

  8. Instrumental activities of daily living at 180 days

    Time frame: 180 days post randomisation

    Physical function measured with instrumental activities of daily living

  9. 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.

  10. 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.

  11. 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

  12. Daily longitudinal ordinal organ support outcome to day 28

    Time frame: 28 days post randomisation

    This includes outcomes on Dead; on ECMO; Off ECMO on IMV; Off IMV, in ICU; On acute hospital ward; Discharged alive

  13. Healthcare costs at day 180

    Time frame: 180 days post randomisation

    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).

  14. Cost-effectiveness at day 180

    Time frame: 180 days post randomisation

    The primary cost-effectiveness analysis will be conducted from the Australian healthcare payer's perspective using an analytical time horizon of 180 days.

Other outcomes

  1. Incidence of adverse events

    Time frame: Up to 28 days post randomisation

    Number of patients who suffered adverse events and serious adverse events such as fall, heart attack or new or increased oozing around cannulae during rehabilitation.

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Collaborators

  • Monash University
  • National Health and Medical Research Council, Australia

Registry information

Official study title

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

Acronym: ECMO-Rehab

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2021
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.