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Early LA Venting During Venoaterial ECMO Support

Primary Purpose

Cardiogenic Shock, Extracorporeal Membrane Oxygenation Support, Refractory Pulmonary Edema

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Left atrial venting
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring Cardiogenic shock, Extracorporeal Membrane Oxygenation Support, Left atrial venting

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early LA venting

Conventional LA venting

Arm 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.

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.

Outcomes

Primary Outcome Measures

weaning rate of VA-ECMO
Weaning of VA-ECMO support

Secondary Outcome Measures

In hospital mortality
Adverse outcome due to LA venting
Free days for mechanical ventilation
Success rate to heart transplantation
rate of improving for pulmonary edema

Full Information

First Posted
October 19, 2018
Last Updated
August 29, 2022
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03740711
Brief Title
Early LA Venting During Venoaterial ECMO Support
Official Title
Early Left Atrial Venting Versus Conventional Treatment For Left Ventricular Decompression During Venoarterial Extracorporeal Membrane Oxygenation Support (EVOLVE-ECMO Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock, Extracorporeal Membrane Oxygenation Support, Refractory Pulmonary Edema
Keywords
Cardiogenic shock, Extracorporeal Membrane Oxygenation Support, Left atrial venting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled test
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early LA venting
Arm Type
Experimental
Arm 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.
Arm Title
Conventional LA venting
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Left atrial venting
Intervention Description
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.
Primary Outcome Measure Information:
Title
weaning rate of VA-ECMO
Description
Weaning of VA-ECMO support
Time Frame
during index admission
Secondary Outcome Measure Information:
Title
In hospital mortality
Time Frame
during index admission
Title
Adverse outcome due to LA venting
Time Frame
during index admission
Title
Free days for mechanical ventilation
Time Frame
during index admission
Title
Success rate to heart transplantation
Time Frame
during index admission
Title
rate of improving for pulmonary edema
Time Frame
during index admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Early LA Venting During Venoaterial ECMO Support

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