Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation

NCT03508505 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2020-03-11

No results posted yet for this study

Summary

Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Suboptimal myocardial protection, technical errors at graft anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.

Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous patient populations, which prevent conclusive results on the benefits of VA-ECMO in this setting. This issue will be investigated in the present retrospective European multicenter study.

In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.

Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous populations of patients who underwent different cardiac procedures. Patients with cardiac low-output after surgery for aortic dissection or valve surgery are expected to have different baseline characteristics (such as age and comorbidities) and underlying cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available studies included patients operated two decades ago and this does not provide an exact measure of the benefits of this treatment strategy.

The possible benefits of using VA-ECMO after adult cardiac surgery will be investigated in this retrospective European multicenter study.

Conditions

  • Acute Heart Failure
  • Low Output Heart Failure
  • Cardiac Output, Low
  • Extracorporeal Membrane Oxygenation
  • Cardiac Surgery
  • Venoarterial Extracorporeal Membrane Oxygenation

Interventions

DEVICE

Venoarterial extracorporeal oxygenation

Veno-arterial extracorporeal oxygenation (VA-ECMO) is inserted in the acute setting in case of cardiac low output after adult cardiac surgery in order to provide cardiopulmonary support to recovery or as bridge to transplantation.

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER
  • Ospedali Riuniti Trieste

    collaborator OTHER
  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER
  • University of Burgundy

    collaborator OTHER
  • CHU de Reims

    collaborator OTHER
  • Rennes University Hospital

    collaborator OTHER
  • Henri Mondor University Hospital

    collaborator OTHER
  • Glenfield Hospital

    collaborator OTHER
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER
  • University Hospital Muenster

    collaborator OTHER
  • Institute for Clinical and Experimental Medicine

    collaborator OTHER_GOV
  • Medical University of Vienna

    collaborator OTHER
  • University Hospital, Udine, Italy

    collaborator OTHER
  • Golden Jubilee National Hospital

    collaborator OTHER_GOV
  • Heinrich-Heine University, Duesseldorf

    collaborator OTHER
  • Helsinki University Central Hospital

    collaborator OTHER
  • Helios Research Center

    collaborator OTHER
  • Sahlgrenska University Hospital

    collaborator OTHER
  • Lund University Hospital

    collaborator OTHER
  • Prince Sultan Cardiac Center, Adult Cardiology Department.

    collaborator OTHER
  • Turku University Hospital

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-06-30
Completion
2020-12-31

Countries

  • Finland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508505 on ClinicalTrials.gov