Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation (PC-ECMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03508505
Recruitment Status : Active, not recruiting
First Posted : April 25, 2018
Last Update Posted : March 11, 2020
Sponsor:
Collaborators:
Karolinska Institutet
Ospedali Riuniti Trieste
Universitätsklinikum Hamburg-Eppendorf
University of Burgundy
CHU de Reims
Rennes University Hospital
Henri Mondor University Hospital
Glenfield Hospital
IRCCS Azienda Ospedaliero-Universitaria di Bologna
University Hospital Muenster
Institute for Clinical and Experimental Medicine
Medical University of Vienna
University Hospital, Udine, Italy
Golden Jubilee National Hospital
Heinrich-Heine University, Duesseldorf
Helsinki University Central Hospital
Helios Research Center
Sahlgrenska University Hospital, Sweden
Lund University Hospital
Prince Sultan Cardiac Center, Adult Cardiology Department.
Information provided by (Responsible Party):
Turku University Hospital

Brief 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.


Condition or disease Intervention/treatment
Acute Heart Failure Low Output Heart Failure Cardiac Output, Low Extracorporeal Membrane Oxygenation Cardiac Surgery Venoarterial Extracorporeal Membrane Oxygenation Device: Venoarterial extracorporeal oxygenation

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • 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.
    Other Names:
    • Cardiac surgery
    • Coronary artery bypass grafting
    • Aortic valve replacement
    • Mitral valve repair
    • Aortic surgery


Primary Outcome Measures :
  1. Hospital death [ Time Frame: Up to 30 days after the index cardiac surgery ]
    All-cause death


Secondary Outcome Measures :
  1. Late death [ Time Frame: Up to 7-year follow-up after the index cardiac surgery ]
    All-cause death

  2. Stroke [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Ischemic infarction or hemorrhagic injury of the brain

  3. Tracheostomy [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Respiratory failure requiring tracheostomy

  4. Gastrointestinal complications [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Gastrointestinal complications requiring surgical treatment

  5. Deep sternal wound infection [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Deep sternal wound infection or mediastinitis

  6. Vascular access site infection [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Infection secondary to any vascular access

  7. Blood stream infection [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Blood stream infection detected at blood cultures

  8. Peripheral vascular injury [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Any aortic and/or peripheral artery complications related to VA-ECMO

  9. Major lower limb amputation [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Major lower limb amputation

  10. New onset dialysis [ Time Frame: Up to 30 days after the index cardiac surgery ]
    New onset dialysis

  11. Peak postoperative serum creatinine level [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Peak postoperative serum creatinine level

  12. Nadir postoperative pH during VA-ECMO [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Nadir postoperative pH during VA-ECMO

  13. Peak postoperative arterial lactate level [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Peak postoperative arterial lactate level

  14. Nadir postoperative hemoglobin level [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Nadir postoperative hemoglobin level

  15. Chest drainage output 24 h after surgery [ Time Frame: Up to 24 hours after the index cardiac surgery ]
    Chest drainage output 24 h after surgery

  16. Number of red blood cells units transfused intra- and postoperatively [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Number of red blood cells units transfused intra- and postoperatively

  17. Reoperation for intrathoracic bleeding [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Reoperation for intrathoracic bleeding

  18. Reoperation for peripheral cannulation-related bleeding [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Reoperation for peripheral cannulation-related bleeding

  19. Intensive care unit length of stay [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Intensive care unit length of stay

  20. Death on VA-ECMO [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Death on VA-ECMO



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who required VA-ECMO for acute heart failure occurring during the index hopsitalization for elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery.
Criteria

Inclusion Criteria:

  • Patients who required VA-ECMO after elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery.

Exclusion Criteria:

  • Any VA-ECMO implanted before index surgical procedure;
  • Patients who underwent postoperatively veno-venous ECMO;
  • Patients who required VA-ECMO after heart transplantation;
  • Patients who required VA-ECMO after any left ventricular assist device.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508505


Locations
Layout table for location information
Finland
Heart Center, Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Karolinska Institutet
Ospedali Riuniti Trieste
Universitätsklinikum Hamburg-Eppendorf
University of Burgundy
CHU de Reims
Rennes University Hospital
Henri Mondor University Hospital
Glenfield Hospital
IRCCS Azienda Ospedaliero-Universitaria di Bologna
University Hospital Muenster
Institute for Clinical and Experimental Medicine
Medical University of Vienna
University Hospital, Udine, Italy
Golden Jubilee National Hospital
Heinrich-Heine University, Duesseldorf
Helsinki University Central Hospital
Helios Research Center
Sahlgrenska University Hospital, Sweden
Lund University Hospital
Prince Sultan Cardiac Center, Adult Cardiology Department.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT03508505    
Other Study ID Numbers: T3/2018
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon request, the investigators will ask the Ethical Committee of the participating centers for permission to share all individual participant data included in this registry with the exception of data through which the patients could be identified.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Turku University Hospital:
Acute Heart Failure
Low Output Heart Failure
Cardiac Low Output
Extracorporeal Membrane Oxygenation
ECMO
Venoarterial Extracorporeal membrane oxygenation
Cardiac Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases