Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-04-27

    Primary completion: 2025-05-30

    Study completion finish: 2025-05-30

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05003609

    Intervention or treatment

    OTHER: Early Rehabilitation

    Conditions

    • Extracorporeal Membrane Oxygenation Complication
    Image related to Extracorporeal Membrane Oxygenation Complication
    • Condition: Extracorporeal Membrane Oxygenation Complication

    • OTHER: Early Rehabilitation

    • Darlinghurst, New South Wales, Australia and more

    • Sponsor: Australian and New Zealand Intensive Care Research Centre

    Find a site

    Closest Location:

    St Vincent's Hospital Sydney

    Research sites nearby

    Select from list below to view details:

    • St Vincent's Hospital Sydney

      Darlinghurst, New South Wales, Australia

    • The Prince Charles Hospital

      Chermside, Queensland, Australia

    • Princess Alexandra Hospital

      Woolloongabba, Queensland, Australia

    • Alfred Health

      Melbourne, Victoria, Australia

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    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?

    Participant Group/ArmIntervention/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.
    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.
    NO_INTERVENTION: Control Group
    • The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation.
    Not specified

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Modified Rankin ScaleThe 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

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Muscle strength at day 14 (Medical Research Council Sum-Score)Grade 0 to Grade 5 where Grade 5 is the best outcome14 days post randomisation
    ECMO-free days to day 28Not Specified28 days post randomisation
    Organ failure free days to day 28Not Specified28 days post randomisation
    Delirium-free days to day 28Not Specified28 days post randomisation
    Activities of Daily Living (ADL) at hospital dischargeNot Specifiedup to day of hospital discharge, an average of 3 months
    Length of stay on ECMO, in ICU and in hospitalNot Specifiedup 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 180Not Specifiedup to 180 days post randomisation
    Instrumental activities of daily living at 180 daysPhysical function measured with instrumental activities of daily living180 days post randomisation
    Montreal Cognitive Assessment (MoCA-Blind)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 180Scoring 10-48 are likely to have clinically significant disability.180 days post randomisation
    Health related quality of life (EQ5D-5L) at day 180Level of severity 1 to 5 where 5 is the most severe180 days post randomisation
    Daily longitudinal ordinal organ support outcome to day 28This includes outcomes on Dead; on ECMO; Off ECMO on IMV; Off IMV, in ICU; On acute hospital ward; Discharged alive28 days post randomisation
    Healthcare costs at day 180Index 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).180 days post randomisation
    Cost-effectiveness at day 180The primary cost-effectiveness analysis will be conducted from the Australian healthcare payer's perspective using an analytical time horizon of 180 days.180 days post randomisation

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    References

    Clinical Trials Gov: Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

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