Mechanical Ventilation ComplicationREDEEMNCT05562505
Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure
A study testing Venovenous ECMO in people with Mechanical Ventilation Complication and Hypoxemia, run by Australian and New Zealand Intensive Care Research Centre at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Ventilation Complication, Hypoxemia, Acute Respiratory Distress Syndrome Due to COVID-19
- What is being tested?
- Venovenous ECMO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 28 Nov 2022to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 to 65 years old
- Acute hypoxemic respiratory failure characterised by new or worsening respiratory symptoms developing within 2 weeks prior to the onset of need for oxygen or respiratory support
- Mechanical ventilation of <7 days
- Moderate to severe respiratory failure, as demonstrated by two P:F ratios <150mmHg at least 6 hours apart. Arterial Blood Gases (ABG) with P:F ratio > 150mmHg are permitted between the two trial inclusion ABGs.
- Trial of proning (unless contraindicated)
Who cannot join
- The patient will be extubated today or tomorrow (i.e. will not remain intubated and ventilated the day after tomorrow)
- Cardiogenic cause of respiratory failure
- Chronic hypercapnic respiratory failure defined as PaCO2 > 60 mmHg in the outpatient setting
- Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep disordered breathing
- Confirmed diffuse alveolar haemorrhage from vasculitis
- Neurologic conditions, i.e. undergoing treatment for intracranial hypertension
Show all 14Show fewer
- Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybrid configuration)
- Patient needing immediate VV ECMO (as per EOLIA criteria)
- The patient is moribund and deemed unlikely to survive past 24 hours (as determined by the clinical team)
- The patient is being transitioned to palliative care
- Contraindications to anticoagulation (e.g., active GI bleeding, bleeding predisposition, severe trauma)
- Previous hypersensitivity/anaphylactic reaction to heparin or heparin-induced thrombocytopenia
- Participation or Consent is declined, OR
- Unable to identify or Contact surrogate decision maker.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Australia6 sites, 6 recruiting
- Recruiting
The Prince Charles Hospital
Brisbane, Queensland
John Fraser
- Recruiting
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Priya Nair
- Recruiting
Gold Coast University Hospital
Gold Coast, Queensland, 4217
James McCullough, Doctor
Mandy Tallott
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Meredith Young
Andrew Udy
- Not yet recruiting
Fiona Stanley Hospital
Perth, Western Australia, 6150
Chris Allen, Doctor
Annamaria Palermo
- Recruiting
Royal Prince Alfred
Sydney, New South Wales
Richard Totaro
Germany1 site, 1 recruiting
- Recruiting
Charite Universitatmedizin
Berlin, 10117
Jan-Matthias Kruse
About this study
Official title: A Randomised Controlled Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure
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.
Read the detailed description
Mechanically ventilated patients with moderate to severe acute hypoxic respiratory failure are at increased risk of dying, short and long-term health problems and are often very costly to treat. The mechanical ventilator, whilst often lifesaving, may harm patients in two ways i) directly via damage to the lungs (termed ventilator induced lung injury), and ii) indirectly via paralysis and sedation that patients require to tolerate mechanical ventilation. Paralysis and sedation can increase the risk of secondary infections, weakness, prolonged duration of intensive care, as well as long-term physical disability. There is a need to develop new treatments that support patients and at the same time reduce these complications.
Extracorporeal membrane oxygenation (ECMO) is a device that supports the lungs by adding oxygen and removing carbon dioxide from the blood. By providing non pulmonary gas exchange, veno-venous (VV) ECMO can reduce the need for the mechanical ventilator. This in turn can reduce the risk of lung damage, and also removes the need for sedating medications so that activities like physiotherapy can begin earlier.
The REDEEM trial is a phase 2, investigator initiated, multicentre randomised controlled trial that will recruit 140 patients with moderate to severe acute hypoxic respiratory failure. It is designed to test whether adding ECMO to the mechanical ventilator, as compared to using the mechanical ventilator on its own, leads to an increase in the number of patients who survive and are discharged earlier from the intensive care unit. If the REDEEM trial confirms adding ECMO is more effective than mechanical ventilation alone, it has the potential to change the current paradigm of intensive care treatment of hypoxic respiratory failure, and could lead to changes in practice globally.
- Conditions
- Mechanical Ventilation Complication, Hypoxemia, Acute Respiratory Distress Syndrome Due to COVID-19, COVID-19 Respiratory Infection, Pneumonia, Extracorporeal Membrane Oxygenation
- Being tested
- Venovenous ECMO
- Keywords
- Intensive Care Unit, ECMO, Extracorporeal Membrane Oxygenation, Mechanical Ventilation, Early ECMO
- Medical subject headings
- Hypoxia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venovenous ECMOOther
ECMO therapy for patients with hypoxic respiratory failure.
| Study group | Role | What they receive |
|---|---|---|
| Venovenous ECMO | Active comparator | Patients allocated to the ECMO strategy be initiated on V-V ECMO and on anticoagulation (blood thinning medication to prevent clot formation) within 24 hours of being allocated into the intervention group. Anticoagulant medication to prevent clot formation will be initiated as per current local practice for each site. Sites are encouraged to use best practice ECMO management that includes de-sedation, extubation, commencement of physiotherapy and rehabilitation, Receives: Other: Venovenous ECMO |
| Standard care | No intervention | Patients allocated to the standard care arm will receive routine intensive care for hypoxic respiratory failure, including mechanical ventilation as per local practices, weaning of sedation and assessment for extubation. Patients who continue to deteriorate will be eligible for initiation of V-V 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care Unit Free days to Day 60
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.
Measured: 60 Days
Secondary outcomes (1)
Daily sedation scores
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.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start28 Nov 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- The Alfred
- Responsible party
- Sponsor
- Investigators
- Aidan Burrell, MBBS, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562505
- Sponsor's protocol ID
- ANZIC-RC/AB002 V2.0
- Acronym
- REDEEM
- Status last verified
- Aug 2024
- First submitted
- 11 Sep 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Management Committee support the view of the International Committee of Medical Journal Editors and the World Health Organisation (WHO) with reference to the ethical obligation to responsibly share data acquired by interventional clinical trials. At the conclusion of the study, the management committee will consider requests from researchers who provide a methodically sound scientific proposal as per the Data Sharing Policy set out in the Australian and New Zealand Intensive Care Research Centre (ANZIC-RC) Terms of Reference. Only de-identified data will be shared and all requests for data must comply with the ethical, regulatory, and legislative requirements governing their jurisdiction.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure
- ClinicalTrials.gov ID
- NCT05562505
- Acronym / sponsor ID
- REDEEM / ANZIC-RC/AB002 V2.0
- Conditions
- Mechanical Ventilation Complication, Hypoxemia, Acute Respiratory Distress Syndrome Due to COVID-19, COVID-19 Respiratory Infection, Pneumonia, Extracorporeal Membrane Oxygenation
- Keywords
- Intensive Care Unit, ECMO, Extracorporeal Membrane Oxygenation, Mechanical Ventilation, Early ECMO
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- The Alfred
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mechanically ventilated patients with moderate to severe acute hypoxic respiratory failure are at increased risk of dying, short and long-term health problems and are often very costly to treat. The mechanical ventilator, whilst often lifesaving, may harm patients in two ways i) directly via damage to the lungs (termed ventilator induced lung injury), and ii) indirectly via paralysis and sedation that patients require to tolerate mechanical ventilation. Paralysis and sedation can increase the risk of secondary infections, weakness, prolonged duration of intensive care, as well as long-term physical disability. There is a need to develop new treatments that support patients and at the same time reduce these complications.
Extracorporeal membrane oxygenation (ECMO) is a device that supports the lungs by adding oxygen and removing carbon dioxide from the blood. By providing non pulmonary gas exchange, veno-venous (VV) ECMO can reduce the need for the mechanical ventilator. This in turn can reduce the risk of lung damage, and also removes the need for sedating medications so that activities like physiotherapy can begin earlier.
The REDEEM trial is a phase 2, investigator initiated, multicentre randomised controlled trial that will recruit 140 patients with moderate to severe acute hypoxic respiratory failure. It is designed to test whether adding ECMO to the mechanical ventilator, as compared to using the mechanical ventilator on its own, leads to an increase in the number of patients who survive and are discharged earlier from the intensive care unit. If the REDEEM trial confirms adding ECMO is more effective than mechanical ventilation alone, it has the potential to change the current paradigm of intensive care treatment of hypoxic respiratory failure, and could lead to changes in practice globally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venovenous ECMO | Active comparator | Other: Venovenous ECMOPatients allocated to the ECMO strategy be initiated on V-V ECMO and on anticoagulation (blood thinning medication to prevent clot formation) within 24 hours of being allocated into the intervention group. Anticoagulant medication to prevent clot formation will be initiated as per current local practice for each site. Sites are encouraged to use best practice ECMO management that includes de-sedation, extubation, commencement of physiotherapy and rehabilitation, |
| Standard care | No intervention | –Patients allocated to the standard care arm will receive routine intensive care for hypoxic respiratory failure, including mechanical ventilation as per local practices, weaning of sedation and assessment for extubation. Patients who continue to deteriorate will be eligible for initiation of V-V 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥18 to 65 years old
- Acute hypoxemic respiratory failure characterised by new or worsening respiratory symptoms developing within 2 weeks prior to the onset of need for oxygen or respiratory support
- Mechanical ventilation of <7 days
- Moderate to severe respiratory failure, as demonstrated by two P:F ratios <150mmHg at least 6 hours apart. Arterial Blood Gases (ABG) with P:F ratio > 150mmHg are permitted between the two trial inclusion ABGs.
- Trial of proning (unless contraindicated)
Key exclusion criteria (14 listed)
- The patient will be extubated today or tomorrow (i.e. will not remain intubated and ventilated the day after tomorrow)
- Cardiogenic cause of respiratory failure
- Chronic hypercapnic respiratory failure defined as PaCO2 > 60 mmHg in the outpatient setting
- Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep disordered breathing
- Confirmed diffuse alveolar haemorrhage from vasculitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venovenous ECMOECMO therapy for patients with hypoxic respiratory failure. | Other | Venovenous ECMO |
Primary outcome
Intensive Care Unit Free days to Day 60
Time frame: 60 Days
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.
1 secondary outcome
Daily sedation scores
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No. The Management Committee support the view of the International Committee of Medical Journal Editors and the World Health Organisation (WHO) with reference to the ethical obligation to responsibly share data acquired by interventional clinical trials. At the conclusion of the study, the management committee will consider requests from researchers who provide a methodically sound scientific proposal as per the Data Sharing Policy set out in the Australian and New Zealand Intensive Care Research Centre (ANZIC-RC) Terms of Reference. Only de-identified data will be shared and all requests for data must comply with the ethical, regulatory, and legislative requirements governing their jurisdiction.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aidan Burrell, MBBS principal investigator
Monash University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venovenous ECMO in people with Mechanical Ventilation Complication and Hypoxemia, run by Australian and New Zealand Intensive Care Research Centre at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie M Hunter (+61 3 9903 0646, Stephanie.Hunter@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Care Unit Free days to Day 60 (time frame: 60 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.