Status:
COMPLETED
The REDEEM Pilot Study: A Feasibility RCT of Early ECMO in Severe Acute Respiratory Infection, Including COVID-19, WHO
Lead Sponsor:
Australian and New Zealand Intensive Care Research Centre
Collaborating Sponsors:
The Alfred
Conditions:
Mechanical Ventilation Complication
Severe Acute Respiratory Infection
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Patients who are critically ill in intensive care with moderate to severe acute respiratory infection often require mechanical ventilation. Prolonged ventilation increases the risk of lung damage and ...
Detailed Description
Prolonged mechanical ventilation is standard care for SARI and is associated with long term functional complications: Current guidelines recommend that mechanical ventilation, including protective lun...
Eligibility Criteria
Inclusion
- Laboratory confirmed severe acute respiratory infection (SARI) pneumonitis such as Coronavirus disease of 2019 (COVID-19) or influenza, AND
- ≥5 days of mechanical ventilation, AND
- Moderate to severe respiratory failure as shown by either the ratio of partial pressure of oxygen and the fracture of inspired oxygen (PaO2:FiO2 Rati)o \<150 for \>6 hours OR the potential of hydrogen (pH) \<7.30 with carbon dioxide (CO2) \>50mmHg for 6 hours, AND
- Are unable to pass a spontaneous breathing trial.
Exclusion
- Age ≥70 year old
- Extubation likely in next 24-48 hours
- Duration of mechanical ventilation ≥7days
- ≥2 non-pulmonary organ failures (as scored by the sequential oxygen failure assessment (SOFA) score)
- Need for immediate VV ECMO (as per EOLIA (research study) criteria\*)
- Requirement for VA ECMO
- Clinical frailty or ≥2 major comorbidities
- The physician deems the study is not in the patient's interest
- EOLIA criteria (P:F \<50 for 3 hours, P:F\<80 for 6 hours, pH\<7.25 with carbon dioxide partial pressure (PCO2) \>60 for \>6 hours
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04708457
Start Date
March 1 2021
End Date
December 31 2022
Last Update
October 4 2023
Active Locations (2)
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1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
2
Charite Universitatmedizin
Berlin, Germany, 10117