Cardiogenic Shock, Extracorporeal Membrane Oxygenation Support, Refractory Pulmonary Edema
Conditions
Keywords
Cardiogenic shock, Extracorporeal Membrane Oxygenation Support, Left atrial venting
Brief summary
The EVOLVE-ECMO(Early Left Atrial Venting Versus Conventional Treatment For Left VEntricular Decompression During Venoarterial ExtraCorporeal Membrane Oxygenation Support) study is a randomized controlled trial to evaluate the prognostic effect of early LA venting(when detect B-line on serial lung ultrasound) on weaning VA-ECMO support in refractory CS who receive VA-ECMO support. The aim of EVOLVE-ECMO trial is to test the hypothesis that early LA venting would result in a significant reduction in failure of weaning ECMO support in refractory CS.
Interventions
PROCEDURELeft atrial venting
The contralateral femoral vein is assessed with an 7-French(Fr) sheath() and femoral artery is assessed with 5-Fr sheath( ) for fluoroscopic guidance using 5-Fr pig-tail catheter. In some cases trans-esophageal echo is used. The inter-atrial septum in punctured with a standard BRK™tran-septal needle(St. Jude Medical Inc., St. Paul, MN) under direct visualization via an 8-Fr Mullin sheath(St. Jude Medical Inc.). A SAFARI™(Boston Scientific, Galway, Ireland) guidewire is advanced into the LA. An 8-Fr Mullin-sheath is removed and atrial septostomy is performed using 21-Fr dilator. A 17-Fr or 21-Fr Biomedicus Percutaneous Femoral cannula(Medtronic Inc., Minneapolis, MN) is then placed in the LA and was attached to the ECMO circuit using a Y connector.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled test
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Subject was \> 18 years of age. * Subjects who underwent successful VA-ECMO support * Subjects with refractory cardiogenic shock who had pulmonary edema confirmed by chest X ray or lung sonogram. * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
* subject was \<80 years of age * Pregnant and/or lactate women * Subjects who underwent VA-ECMO after recent open heart surgery * Subjects who underwent VA-ECMO after non-cardiogenic arrest(trauma, hypothermia, submersion, drug overdose, asphyxia, intracranial hemorrhage etc) * Severe bleeding tendency * Terminal malignancy * Known severe irreversible brain damage * Subject was unable to provide written informed consent or participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weaning rate of VA-ECMO | during index admission | Weaning of VA-ECMO support |
Secondary
| Measure | Time frame |
|---|---|
| In hospital mortality | during index admission |
| Adverse outcome due to LA venting | during index admission |
| Free days for mechanical ventilation | during index admission |
| Success rate to heart transplantation | during index admission |
| rate of improving for pulmonary edema | during index admission |
Countries
South Korea
Outcome results
None listed