A Randomised Controlled Trial of Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded outcome assessor - blinded / different therapist (strength) and central follow-up for blinded assessment of PROMs
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Modified Rankin Scale
时间窗: 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).
次要结局
- Muscle strength at day 14 (Medical Research Council Sum-Score)(14 days post randomisation)
- ECMO-free days to day 28(28 days post randomisation)
- Organ failure free days to day 28(28 days post randomisation)
- Delirium-free days to day 28(28 days post randomisation)
- Activities of Daily Living (ADL) at hospital discharge(up to day of hospital discharge, an average of 3 months)
- 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)
- Mortality rate at ICU and hospital discharge, day 90 and day 180(up to 180 days post randomisation)
- Instrumental activities of daily living at 180 days(180 days post randomisation)
- Montreal Cognitive Assessment (MoCA-Blind)(180 days post randomisation)
- WHO Disability Assessment Schedule 2.0 at day 180(180 days post randomisation)
- Health related quality of life (EQ5D-5L) at day 180(180 days post randomisation)
- Daily longitudinal ordinal organ support outcome to day 28(28 days post randomisation)
- Healthcare costs at day 180(180 days post randomisation)
- Cost-effectiveness at day 180(180 days post randomisation)