Early LA Venting During Venoaterial ECMO Support

Asan Medical Center

Status: Completed

Conditions: Refractory Pulmonary Edema; Cardiogenic Shock; Extracorporeal Membrane Oxygenation Support

Treatments: Procedure: Left atrial venting

Study type: Interventional

Funder types: Other

Identifiers

NCT03740711

AMC_2018_0646

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Early LA venting

Experimental group

Description:

When detect B-line on serial lung ultrasound, we will perform early LA venting for improving LV distention in patients with refractory cardiogenic shock who received VA-ECMO support.

Treatment:

Procedure: Left atrial venting

Conventional LA venting

Active Comparator group

Description:

When detect refractory pulmonary congestion on chest radiograph or inadequate AV opening on serial echocardiography, we will perform LA venting for improving LV distention in patients with refractory cardiogenic shock who received VA-ECMO support.

Treatment:

Procedure: Left atrial venting