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Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure

RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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)

Exclusion criteria

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

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-11-28

Primary completion: 2026-07-31

Study completion finish: 2027-01-31

Study type

TREATMENT

Phase

Trial ID

NCT05562505

Intervention or treatment

OTHER: Venovenous ECMO

Conditions

• Extracorporeal Membrane Oxygenation
• Mechanical Ventilation Complication
• Hypoxemia
• Acute Respiratory Distress Syndrome Due to COVID-19
• COVID-19 Respiratory Infection
• Pneumonia

Image related to Extracorporeal Membrane Oxygenation

Condition: Extracorporeal Membrane Oxygenation, Mechanical Ventilation Complication and more
OTHER: Venovenous ECMO
Darlinghurst, New South Wales, Australia and more
Sponsor: Australian and New Zealand Intensive Care Research Centre

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

St Vincent's Hospital Sydney

Research sites nearby

Select from list below to view details:

St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia
Royal Prince Alfred
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Venovenous ECMO 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,	OTHER: Venovenous ECMO ECMO therapy for patients with hypoxic respiratory failure.
NO_INTERVENTION: Standard care 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.	Not specified

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Venovenous ECMO

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,

OTHER: Venovenous ECMO

ECMO therapy for patients with hypoxic respiratory failure.

NO_INTERVENTION: Standard care

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.

Not specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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.	60 Days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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.	Day 28

Frequently Asked Questions

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References

Clinical Trials Gov: Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure