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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05562505
Registration number
NCT05562505
Ethics application status
Date submitted
11/09/2022
Date registered
30/09/2022
Date last updated
30/09/2022
Titles & IDs
Public title
Trial of ECMO to De-Sedate, Extubate Early and Mobilise in Hypoxic Respiratory Failure
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Scientific title
A Randomised Controlled Trial of ECMO to De-Sedate, Extubate Early and Mobilise in Hypoxic Respiratory Failure
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Secondary ID [1]
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ANZIC-RC/AB002 V2.0
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Universal Trial Number (UTN)
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Trial acronym
REDEEM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mechanical Ventilation Complication
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Hypoxemia
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Acute Respiratory Distress Syndrome Due to COVID-19
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COVID-19 Respiratory Infection
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Pneumonia
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Extracorporeal Membrane Oxygenation
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Infection
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Studies of infection and infectious agents
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Reproductive Health and Childbirth
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Complications of newborn
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Injuries and Accidents
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Venovenous ECMO
Active Comparator: Venovenous ECMO - Patients allocated to the ECMO strategy be initiated on VV ECMO and commenced on anticoagulation within <24 hours after being enrolled. Following VV ECMO initiation, the sweep gas will be gradually turned up to target a respiratory alkalosis (pH > 7.45; maximum 20% increase every 6 hours; PaCo2 < 35 mmHg), to reduce the patient's intrinsic respiratory drive. Following this, the patient will be de-sedated, and when clinically appropriate, extubated. The awake patient will be assessed daily to participate in physiotherapy: which includes sitting up, sitting out of bed, speech assessment and, where appropriate, mobilisation.
No Intervention: Standard care - Patients allocated to the standard care arm will receive routine intensive care for hypoxic respiratory failure, including mechanical ventilation with a lung protective strategy (low tidal volumes, pressures and positive end expiratory pressure titration), weaning of sedation and assessment for extubation. Patients who continue to deteriorate will be eligible for initiation of VV ECMO if they meet the ECMO to rescue lung injury in severe ARDS (EOLIA) criteria: Partial pressures of arterial oxygen (PaO2):Fraction of inspired oxygen (FiO2)<50 for 3 hours, PaO2:FiO2<80 for 6 hours, pH<7.25 with PaCO2 >60 for >6 hours.
Other interventions: Venovenous ECMO
ECMO therapy for patients with hypoxic respiratory failure.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Intensive Care Unit Free days to Day 60
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Assessment method [1]
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Days alive and free from ICU to Day 60. Day Day 0 is randomisation day, with any portion of a day is spent in an ICU counted as a day.
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Timepoint [1]
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60 Days
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Secondary outcome [1]
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Daily sedation scores
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Assessment method [1]
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Highest (+4 Combative) and lowest (-5 Unarousable) daily Richmond Agitation and Sedation Scores (RASS). The optimal score for early mobilisation of participants on ECMO is 0 Alert and Calm.
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Timepoint [1]
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Day 28
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Eligibility
Key inclusion criteria
- Mechanically ventilated for hypoxic respiratory failure
- Mechanical ventilation for =3days
- Moderate to severe respiratory failure on the day of inclusion, as demonstrated by:
PaO2:FiO2 Ratio <150 for >6 hours despite protective lung ventilation (including tidal
volume <6mls/kg predicted body weight),
- Trial of proning according to local protocol.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Mechanical ventilation duration >7days
- Need for immediate VV ECMO
- Clinical Frailty Score of >4
- Patient being actively weaned from mechanical ventilation
- Requirement for veno-arterial (VA) ECMO
- Severe coagulopathy (INR=2.0, platelets < 100 or activated partial thromboplastin time
(APTT) >50 seconds)
- Vascular access not suitable for ECMO (includes inferior vena cava filter, deep vein
thrombosis, abnormal anatomy, existing femoral access)
- Insufficient equipment or personnel to commence ECMO
- Death is deemed imminent by the treating clinician
- The physician deems the study is not in the patient's interest
- Participation or Consent is declined OR
- Unable to identify medical treatment decision maker.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/11/2022
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/01/2027
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Actual
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Sample size
Target
140
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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St Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [2]
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Royal Prince Alfred - Sydney
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Recruitment hospital [3]
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The Prince Charles Hospital - Brisbane
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Recruitment hospital [4]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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- Sydney
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Recruitment postcode(s) [3]
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- Brisbane
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Berlin
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Alfred
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
To determine whether a strategy of adding venovenous ECMO to mechanical ventilation, as
compared to mechanical ventilation alone, increases the number of intensive care free days at
day 60, in patients with moderate to severe acute hypoxic respiratory failure.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05562505
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Aidan Burrell, MBBS
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Stephanie M Hunter
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Address
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Country
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Phone
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+61 3 9903 0646
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05562505
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