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

August 28, 2023 updated by: Armin N. Flinspach, Goethe University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

veno-venous extracorporeal membrane oxygenation

Exclusion Criteria:

veno-arterial extracorporeal membrane oxygenation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: During intensive care treatment (Usually within 25 weeks)
Mortality rate under ongoing veno-venous extracorporeal membrane oxygenation over time
During intensive care treatment (Usually within 25 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

April 14, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prolonged VV-ECMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing patient data is not possible due to national and local legal restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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