Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.

NCT05338593 | Completed

• 1 other identifier: prolonged VV-ECMO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In the context of the coronavirus (COVID-19) pandemic, healthcare systems worldwide faced an unprecedented shortage of severe ARDS. Critically affected patients were treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO) for complete respiratory failure early in the pandemic. Due to a shortage of resources in the sense of terminal equipment and adequately trained personnel with appropriate expertise in many countries and regions, a strict selection of suitable patients was made. Repeatedly, it was observed that patients under VV-ECMO also needed several weeks to recover sufficiently to generate device sufficient gas exchange. Due to the scarcity of VV-ECMO resources outside of the pandemic, the question arose whether a prolonged therapy still holds a sufficient prospect of success and what the course of treatment of such patients would be like.

Conditions

Extracorporeal Membrane Oxygenation Complication; Outcome, Fatal

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality rate under ongoing veno-venous extracorporeal membrane oxygenation over time

  During intensive care treatment (Usually within 25 weeks)

Secondary Outcomes (2)

• Major bleeding

  During intensive care treatment (Usually within 25 weeks)

• critical device error

  During intensive care treatment (Usually within 25 weeks)

Study Arms (1)

prolonged veno-venous extracorporeal membrane oxygenation

Critically affected patients treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Based on severe acute respiratory distress syndrome (ARDS) and prolonged therapy for more than 2 weeks.

Other: Outcome

Interventions

Outcome OTHER

Mortality rate of prolonged therapy.

prolonged veno-venous extracorporeal membrane oxygenation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically affected patients treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Based on severe acute respiratory distress syndrome (ARDS) and prolonged therapy for more than 2 weeks.

You may qualify if:

• veno-venous extracorporeal membrane oxygenation

You may not qualify if:

• veno-arterial extracorporeal membrane oxygenation

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Study Officials

• Armin N Flinspach, M.D.

  JWGoethe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 15, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)