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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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
TREATMENT
Phase
NA
Trial ID
NCT05003609
Intervention or treatment
OTHER: Early Rehabilitation
Conditions
- • Extracorporeal Membrane Oxygenation Complication
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
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/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Intervention Group
| OTHER: Early Rehabilitation
|
NO_INTERVENTION: Control Group
| Not specified |
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 |
ECMO-free days to day 28 | Not Specified | 28 days post randomisation |
Organ failure free days to day 28 | Not Specified | 28 days post randomisation |
Delirium-free days to day 28 | Not Specified | 28 days post randomisation |
Activities of Daily Living (ADL) at hospital discharge | Not Specified | up to day of hospital discharge, an average of 3 months |
Length of stay on ECMO, in ICU and in hospital | Not Specified | 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 | Not Specified | up to 180 days post randomisation |
Instrumental activities of daily living at 180 days | Physical function measured with instrumental activities of daily living | 180 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 180 | Scoring 10-48 are likely to have clinically significant disability. | 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 | 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 | 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). | 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. | 180 days post randomisation |
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