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

NCT04708457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-10-04

No results posted yet for this study

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

Interventions

OTHER

VV-ECMO

Early use of VV-ECMO in SARI patients.

Sponsors & Collaborators

  • The Alfred

    collaborator OTHER

  • Australian and New Zealand Intensive Care Research Centre

    lead OTHER

Principal Investigators

  • Aidan Burrell, MBBS · The Alfred

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-05-01
Completion
2022-12-31

Countries

  • Australia
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04708457 on ClinicalTrials.gov