Early LA Venting During Venoaterial ECMO Support

Not Applicable

Completed

• Conditions: Cardiogenic Shock; Extracorporeal Membrane Oxygenation Support; Refractory Pulmonary Edema
• Interventions: Procedure: Left atrial venting

• Registration Number: NCT03740711
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-11-11
• Study First Posted: 2018-11-14
• Study Start: 2018-12-12
• Status Verified: 2022-08
• Primary Completion: 2022-08-24
• Last Update Submitted: 2022-08-29
• Study Completion: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional LA venting	Left atrial venting	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.
Early LA venting	Left atrial venting	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.

Primary Outcome Measures

Name	Time	Method
weaning rate of VA-ECMO	during index admission	Weaning of VA-ECMO support

Secondary Outcome Measures

Name	Time	Method
Success rate to heart transplantation	during index admission
In hospital mortality	during index admission
Adverse outcome due to LA venting	during index admission
Free days for mechanical ventilation	during index admission
rate of improving for pulmonary edema	during index admission

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of