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

• Sponsor: Goethe University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05338593
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 12.5
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extracorporeal Membrane Oxygenation Complication; Outcome, Fatal	Other: Outcome

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
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; Mortality rate of prolonged therapy.

Outcome Measures

Primary Outcome Measures

1. Mortality [During intensive care treatment (Usually within 25 weeks)]

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

Secondary Outcome Measures

1. Major bleeding [During intensive care treatment (Usually within 25 weeks)]

   Number of patients with critical bleeding events during therapy, needing red blood cell transfusion

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

veno-venous extracorporeal membrane oxygenation

Exclusion Criteria:

veno-arterial extracorporeal membrane oxygenation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Frankfurt	Frankfurt	Hessen	Germany	60590

Sponsors and Collaborators

• Goethe University

Investigators

• Principal Investigator: Armin N Flinspach, M.D., JWGoethe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Armin N. Flinspach, Principal Investigator, Goethe University
• ClinicalTrials.gov Identifier: NCT05338593
• Other Study ID Numbers: prolonged VV-ECMO
• First Posted: Apr 21, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Aug 5, 2022