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

Completed

• Conditions: Extracorporeal Membrane Oxygenation Complication; Outcome, Fatal
• Interventions: Other: Outcome

• Registration Number: NCT05338593
• Lead Sponsor: Goethe University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-21
• Study Start: 2022-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

veno-venous extracorporeal membrane oxygenation

Exclusion Criteria

veno-arterial extracorporeal membrane oxygenation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
prolonged veno-venous extracorporeal membrane oxygenation	Outcome	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.

Primary Outcome Measures

Name	Time	Method
Mortality	During intensive care treatment (Usually within 25 weeks)	Mortality rate under ongoing veno-venous extracorporeal membrane oxygenation over time

Secondary Outcome Measures

Name	Time	Method
Major bleeding	During intensive care treatment (Usually within 25 weeks)	Number of patients with critical bleeding events during therapy, needing red blood cell transfusion
critical device error	During intensive care treatment (Usually within 25 weeks)	Number of patients with a critical device errors of the veno-venous extracorporeal membrane oxygenation device.

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany