Status:
COMPLETED
Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation
Lead Sponsor:
Chonnam National University Hospital
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The use of venoarterial-extracorporeal membrane oxygenation(VA-ECMO) was associated with lower in-hospital mortality in patients with cardiogenic shock. However, VA-ECMO has a deleterious effect for h...
Detailed Description
Study Objectives: To determine the effect of early left atrial septostomy versus conventional approach(left atrial septostomy only in cases of significant changes due to left ventricular end-diastoli...
Eligibility Criteria
Inclusion
- 1\) Age more than 18 years old 2) Cardiogenic shock\* 3) Successful VA-ECMO implantation
- The definition of cardiogenic shock All these criteria should be met
- Systolic blood pressure \< 90 mmHg for 30 minutes, or needing inotrope or vasopressor to maintain systolic blood pressure \> or = 90 mmHg
- Pulmonary congestion on chest X-ray or increased left ventricular filling pressure by cardiac catheterization
- At least one criteria of organ dysfunction
- \- mental obtundation, clammy skin, oliguria, renal dysfunction, increased level of blood lactate
Exclusion
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- VA-ECMO after open heart surgery
- VA-ECMO for the treatment of non-cardiac shock
- Severe bleeding\*
- Terminal malignancy
- Irreversible brain damage
- Pregnancy or lactation
- The definition of severe bleeding Hemoglobin decrease after VA-ECMO or cannulation site bleeding is not a exclusion criteria
- Hypovolemic shock due to definite bleeding cause
- Identifiable bleeding causes: gastrointestinal bleeding, hemothorax, traumatic bleeding, central nervous system hemorrhage, pulmonary hemorrhage
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04775472
Start Date
March 4 2021
End Date
October 31 2023
Last Update
January 12 2024
Active Locations (1)
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1
Chonnam National University Hospital
Gwangju, South Korea