Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
A Randomised Controlled Trial of ECMO to De-Sedate, Extubate Early and Mobilise in Hypoxic Respiratory Failure
Secondary ID [1] 0 0
ANZIC-RC/AB002 V2.0
Universal Trial Number (UTN)
Trial acronym
REDEEM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical Ventilation Complication 0 0
Hypoxemia 0 0
Acute Respiratory Distress Syndrome Due to COVID-19 0 0
COVID-19 Respiratory Infection 0 0
Pneumonia 0 0
Extracorporeal Membrane Oxygenation 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Intensive Care Unit Free days to Day 60
Timepoint [1] 0 0
60 Days
Secondary outcome [1] 0 0
Daily sedation scores
Timepoint [1] 0 0
Day 28

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Royal Prince Alfred - Sydney
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05562505
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aidan Burrell, MBBS
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stephanie M Hunter
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 0646
Fax 0 0
Email 0 0
Stephanie.Hunter@monash.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05562505