Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

N/AActive Not RecruitingNCT05003609

Australian and New Zealand Intensive Care Research Centre100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Extracorporeal Membrane Oxygenation Complication

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

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

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Toronto General Hospital

Toronto, Canada

Outcomes

Primary Outcomes

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).

Time frame: 180 days post randomisation

Secondary Outcomes

Muscle strength at day 14 (Medical Research Council Sum-Score)

Grade 0 to Grade 5 where Grade 5 is the best outcome

Time frame: 14 days post randomisation

ECMO-free days to day 28

Time frame: 28 days post randomisation

Organ failure free days to day 28

Time frame: 28 days post randomisation

Delirium-free days to day 28

Time frame: 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

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

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

Time frame: up to 180 days post randomisation

Instrumental activities of daily living at 180 days

Physical function measured with instrumental activities of daily living

Time frame: 180 days post randomisation

Montreal Cognitive Assessment (MoCA-Blind)

Rapid screening instrument for mild cognitive dysfunction. Normal is equal or more than 18 points.

Time frame: 180 days post randomisation

WHO Disability Assessment Schedule 2.0 at day 180

Scoring 10-48 are likely to have clinically significant disability.

Time frame: 180 days post randomisation

Health related quality of life (EQ5D-5L) at day 180

Level of severity 1 to 5 where 5 is the most severe

Time frame: 180 days post randomisation

Daily longitudinal ordinal organ support outcome to day 28

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

Time frame: 28 days post randomisation

Healthcare costs at day 180

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).

Time frame: 180 days post randomisation

Cost-effectiveness at day 180

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

Time frame: 180 days post randomisation

Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes