Trial Review

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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
Date last updated
4/10/2023

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
Not applicable
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
Patients who are critically ill in intensive care with moderate to severe acute respiratory infection often require mechanical ventilation. Prolonged ventilation increases the risk of lung damage and other side effects as a result of long term use of sedation medications. Extracorporeal membrane oxygenation therapy (ECMO), is a relatively new technology that uses a pump to remove blood from the body and return it back to the body after adding oxygen and removing carbon dioxide. ECMO can be used on patients who require mechanical ventilation and can function without the need for ongoing mechanical ventilation, thus reducing risk of side effects. Participants will be randomised into either the early ECMO therapy group or will continue standard treatment involving mechanical ventilation.

This pilot study aims to determine if a phase 3 Randomised Control Trial (RCT) is feasible for the use of early ECMO therapy to treat patients with Severe Acute Respiratory Infection (SARI). The success of the study will be determined by the successful recruitment of adult patients, that there is a difference between ECMO utilisation between groups and that there are no safety issues.
Trial website
https://clinicaltrials.gov/study/NCT04708457
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04708457