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

Last updated: August 6, 2024
Sponsor: Australian and New Zealand Intensive Care Research Centre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pneumonia

Acute Respiratory Distress Syndrome (Ards)

Respiratory Failure

Treatment

Venovenous ECMO

Clinical Study ID

NCT05562505
ANZIC-RC/AB002 V2.0
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients ≥18 to 65 years old

  2. Acute hypoxemic respiratory failure characterised by new or worsening respiratorysymptoms developing within 2 weeks prior to the onset of need for oxygen orrespiratory support

  3. Mechanical ventilation of <7 days

  4. Moderate to severe respiratory failure, as demonstrated by two P:F ratios <150mmHgat least 6 hours apart. Arterial Blood Gases (ABG) with P:F ratio > 150mmHg arepermitted between the two trial inclusion ABGs.

  5. Trial of proning (unless contraindicated)

Exclusion

Exclusion Criteria:

  1. The patient will be extubated today or tomorrow (i.e. will not remain intubated andventilated the day after tomorrow)

  2. Cardiogenic cause of respiratory failure

  3. Chronic hypercapnic respiratory failure defined as PaCO2 > 60 mmHg in the outpatientsetting

  4. Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except forCPAP/BIPAP used solely for sleep disordered breathing

  5. Confirmed diffuse alveolar haemorrhage from vasculitis

  6. Neurologic conditions, i.e. undergoing treatment for intracranial hypertension

  7. Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybridconfiguration)

  8. Patient needing immediate VV ECMO (as per EOLIA criteria)

  9. The patient is moribund and deemed unlikely to survive past 24 hours (as determinedby the clinical team)

  10. The patient is being transitioned to palliative care

  11. Contraindications to anticoagulation (e.g., active GI bleeding, bleedingpredisposition, severe trauma)

  12. Previous hypersensitivity/anaphylactic reaction to heparin or heparin-inducedthrombocytopenia

  13. Participation or Consent is declined, OR

  14. Unable to identify or Contact surrogate decision maker.

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Venovenous ECMO
Phase:
Study Start date:
November 28, 2022
Estimated Completion Date:
January 31, 2027

Study 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.

Connect with a study center

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Royal Prince Alfred

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • The Prince Charles Hospital

    Brisbane, Queensland
    Australia

    Active - Recruiting

  • Gold Coast University Hospital

    Gold Coast, Queensland 4217
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Perth, Western Australia 6150
    Australia

    Site Not Available

  • Charite Universitatmedizin

    Berlin, 10117
    Germany

    Active - Recruiting

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