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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04708457




Registration number
NCT04708457
Ethics application status
Date submitted
4/12/2020
Date registered
14/01/2021

Titles & IDs
Public title
The REDEEM Pilot Study: A Feasibility RCT of Early ECMO in Severe Acute Respiratory Infection, Including COVID-19, WHO
Scientific title
A Pilot Feasibility RCT of Early ECMO to DE-sedate, Extubate, and Mobilise in Severe Acute Respiratory Infection
Secondary ID [1] 0 0
ANZIC-RC/AB V3.1
Universal Trial Number (UTN)
Trial acronym
REDEEM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical Ventilation Complication 0 0
Severe Acute Respiratory Infection 0 0
Covid19 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - VV-ECMO

Active comparator: Early ECMO - Early ECMO therapy for patients who have SARI and have been mechanically ventilated for 5-7 days.

No intervention: Standard Care - Patients with SARI who are already mechanically ventilated will continue to receive the standard intensive care therapies, including ECMO if required.


Other interventions: VV-ECMO
Early use of VV-ECMO in SARI patients.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants who have SARI and have been mechanically ventilated for at least 5 days.
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
1. Laboratory confirmed severe acute respiratory infection (SARI) pneumonitis such as Coronavirus disease of 2019 (COVID-19) or influenza, AND
2. =5 days of mechanical ventilation, AND
3. Moderate to severe respiratory failure as shown by either the ratio of partial pressure of oxygen and the fracture of inspired oxygen (PaO2:FiO2 Rati)o <150 for >6 hours OR the potential of hydrogen (pH) <7.30 with carbon dioxide (CO2) >50mmHg for 6 hours, AND
4. Are unable to pass a spontaneous breathing trial.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age =70 year old
2. Extubation likely in next 24-48 hours
3. Duration of mechanical ventilation =7days
4. =2 non-pulmonary organ failures (as scored by the sequential oxygen failure assessment (SOFA) score)
5. Need for immediate VV ECMO (as per EOLIA (research study) criteria*)
6. Requirement for VA ECMO
7. Clinical frailty or =2 major comorbidities
8. The physician deems the study is not in the patient's interest

* EOLIA criteria (P:F <50 for 3 hours, P:F<80 for 6 hours, pH<7.25 with carbon dioxide partial pressure (PCO2) >60 for >6 hours

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aidan Burrell, MBBS
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04708457