NCT05342363

Brief Summary

In-hospital cardiovascular arrest is associated with poor outcome despite prompt treatment and optimal on-site resources. The population of patients treated by venovenous extracorporeal membrane oxygenation (vv-ECMO) due to pulmonary failure is a very challenging group of patients. To date, the frequency, causes and outcome of cardiovascular arrest in these patients have not been studied. We are aiming to conduct a retrospective observational study of all vv-ECMO patients treated at our ARDS centre.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

April 16, 2022

Last Update Submit

August 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival of mechanical cardiovascular resuscitation

    Survival of mechanical cardiovascular resuscitation

    During the intensive care stay ( usually between 2 and 8 weeks)

Secondary Outcomes (2)

  • Incidence of cardiovascular resuscitation i

    During the observation period 2019-2022

  • Complications of resuscitation treatments

    During the intensive care stay ( usually between 2 and 8 weeks)

Study Arms (2)

cardiopulmonary resuscitation during treatment with extracorporeal membrane oxygenation

Patients treated with venovenous extracorporeal membrane oxygenation (vv-ECMO) for acute respiratory distress syndrome (ARDS) during the retrospective observation period who required mechanical cardiovascular resuscitation (CPR) during their treatment.

Treatment with extracorporeal membrane oxygenation without resuscitation

Patients treated with venovenous extracorporeal membrane oxygenation (vv-ECMO) for acute respiratory distress syndrome (ARDS) without the need for cardiovascular resuscitation during the retrospective observation period.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) for respiratory failure in acute respiratory distress syndrome (ARDS). And in addition required mechanical cardiovascular resuscitation treatment during existing therapy with veno-venous extracorporeal membrane oxygenation (vv-ECMO).

You may qualify if:

  • Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) due to respiratory failure during acute respiratory distress syndrome (ARDS).

You may not qualify if:

  • Patients treated with veno-arterial extracorporeal membrane oxygenation (va-ECMO)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 16, 2022

First Posted

April 22, 2022

Study Start

June 1, 2022

Primary Completion

May 1, 2023

Study Completion

August 1, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Sharing patient data with third parties is subject to national and local law restrictions and regrettably not possible.

Locations