A Randomised Controlled Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mechanical Ventilation Complication
- Sponsor
- Australian and New Zealand Intensive Care Research Centre
- Enrollment
- 140
- Locations
- 7
- Primary Endpoint
- Intensive Care Unit Free days to Day 60
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Daily sedation scores(Day 28)