The REDEEM Pilot Study: A Feasibility RCT of Early ECMO in Severe Acute Respiratory Infection, Including COVID-19, WHO

NCT04708457 | Completed DMC

• 1 other identifier: ANZIC-RC/AB V3.1
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 2

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 other side effects as a result of long term use of sedation medications. Extracorporeal membrane oxygenation therapy (ECMO), is a relatively new technology that uses a pump to remove blood from the body and return it back to the body after adding oxygen and removing carbon dioxide. ECMO can be used on patients who require mechanical ventilation and can function without the need for ongoing mechanical ventilation, thus reducing risk of side effects. Participants will be randomised into either the early ECMO therapy group or will continue standard treatment involving mechanical ventilation. This pilot study aims to determine if a phase 3 Randomised Control Trial (RCT) is feasible for the use of early ECMO therapy to treat patients with Severe Acute Respiratory Infection (SARI). The success of the study will be determined by the successful recruitment of adult patients, that there is a difference between ECMO utilisation between groups and that there are no safety issues.

Conditions

Mechanical Ventilation Complication; Severe Acute Respiratory Infection; Covid19

Keywords

Intensive Care Unit; ECMO; Extracorporeal membrane oxygenation; Mechanical ventilation; Early ECMO

Outcome Measures

Primary Outcomes (1)

• Number of participants who have SARI and have been mechanically ventilated for at least 5 days.

  The number of participants who have SARI and have been mechanically ventilated for at least 5 days but no more than 7 days are eligible to participate in this study. The number of patients that meet this criteria will help assess the feasibility of this study.

  12 months

Study Arms (2)

Early ECMO

ACTIVE COMPARATOR

Early ECMO therapy for patients who have SARI and have been mechanically ventilated for 5-7 days.

Other: VV-ECMO

Standard Care

NO INTERVENTION

Patients with SARI who are already mechanically ventilated will continue to receive the standard intensive care therapies, including ECMO if required.

Interventions

VV-ECMO OTHER

Early use of VV-ECMO in SARI patients.

Early ECMO

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead
• The Alfred: collaborator

Study Sites (2)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Charite Universitatmedizin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aidan Burrell, MBBS

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: January 14, 2021
• Study Start: March 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: December 31, 2022
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); AU (1)