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

Pneumonia Clinical Trial

— REDEEM  

Official title:

A Randomised Controlled Trial of ECMO to De-Sedate, Extubate Early and Mobilise in Hypoxic Respiratory Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05562505
• Other study ID #: ANZIC-RC/AB002 V2.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: January 31, 2027

Study information

• Verified date: September 2022
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: Stephanie M Hunter
• Phone: +61 3 9903 0646
• Email: Stephanie.Hunter[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: January 31, 2027
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• Extracorporeal Membrane Oxygenation
• Hypoxemia
• Hypoxia
• Mechanical Ventilation Complication
• Pneumonia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency
• Respiratory Tract Infections

Intervention

Other:
• Venovenous ECMO
ECMO therapy for patients with hypoxic respiratory failure.

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Brisbane	Queensland
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Royal Prince Alfred	Sydney	New South Wales
Germany	Charite Universitatmedizin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	The Alfred

Countries where clinical trial is conducted

Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Extubation rates	Date and time of enduring extubation	Day 28
Other	Participation in early mobilisation	Daily assessment for mobilisation by allied health clinicians using the ICU Mobility Scale. The ICU Mobility Scale ranges from 0-Lying in Bed, to 10-Walking Independently without a Gait Aid. Score 7-Walking With the Assistance of 2 or More People is the best outcome achievable for participants on ECMO.	Day 28
Other	Number of Participants who were randomised to standard care initially and subsequently needed VV-ECMO.	Number of Participants who were randomised to standard care initially and subsequently needed VV-ECMO.	Day 28
Other	WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	Assessment of 6 domains of functioning for participants at Day 180 follow up via telephone interview. Total possible scores are 48. A lower score indicates a better outcome.	Day 180
Other	EuroQol EQ5D-5L	Health-related quality of life reported via telephone interview at Day 180 using the EuroQol EQ5D. Total possible scores are 25. A lower score indicates a better outcome.	Day 180
Primary	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	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