Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation

Cardiogenic Shock Clinical Trial

— EARLY-UNLOAD  

Official title:

Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04775472
• Other study ID #: CNUH-2020-390
• Status: Completed
• Phase: N/A
• Start date: March 4, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2024
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 hemodynamics. It can increase left ventricular end-diastolic pressure(LVEDP), followed by left ventricular dilatation, abnormal opening of aortic valve and jeopardizes of myocardial recovery. Therefore, several methods have been used to reduce LVEDP. Among these, left atrial septostomy is effective, but less invasive than surgical left ventricular unloading. However, there is few data regarding this issue. Therefore, the investigators will evaluate the effect of routine, early left atrial septostomy in patients with VA-ECMO for the treatment of cardiogenic shock.

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-diastolic pressure increase) in patients who received venoarterial-extracorporeal membrane oxygenation(VA-ECMO) for the treatment of cardiogenic shock. Study Background: Cardiogenic shock is due to myocardial dysfunction from multifactorial causes, which has high mortality. The treatment for cardiogenic shock includes early coronary revascularization, inotropes, vasopressors, or mechanical circulatory support, such as intraaortic balloon pump(IABP), VA-ECMO. However, the routine use of IABP is not recommended for the treatment of cardiogenic shock in recent guidelines. VA-ECMO can be easily implanted, and can maintain high cardiac output. In several studies, The use of VA-ECMO was associated with lower in-hospital mortality in patients with cardiogenic shock. However, VA-ECMO has a deleterious effect for hemodynamics. It can increase left ventricular end-diastolic pressure(LVEDP), followed by left ventricular dilatation, abnormal opening of aortic valve and jeopardizes of myocardial recovery. Therefore, several methods have been used to reduce LVEDP. Among these, left atrial septostomy is effective, but less invasive than surgical left ventricular unloading. However, there is few data regarding this issue. Therefore, the investigators will evaluate the effect of routine, early left atrial septostomy in patients with VA-ECMO for the treatment of cardiogenic shock. Study Hypothesis: Early, routine left atrial septostomy for left heart unloading is superior compared to conventional approach to reduce in-hospital mortality and the duration of VA-ECMO.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: October 31, 2023
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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

1. Systolic blood pressure < 90 mmHg for 30 minutes, or needing inotrope or vasopressor to maintain systolic blood pressure > or = 90 mmHg

2. Pulmonary congestion on chest X-ray or increased left ventricular filling pressure by cardiac catheterization

3. At least one criteria of organ dysfunction

• mental obtundation, clammy skin, oliguria, renal dysfunction, increased level of blood lactate

Exclusion Criteria:

1. VA-ECMO after open heart surgery

2. VA-ECMO for the treatment of non-cardiac shock

3. Severe bleeding*

4. Terminal malignancy

5. Irreversible brain damage

6. Pregnancy or lactation

• The definition of severe bleeding Hemoglobin decrease after VA-ECMO or cannulation site bleeding is not a exclusion criteria

1. Hypovolemic shock due to definite bleeding cause

2. Identifiable bleeding causes: gastrointestinal bleeding, hemothorax, traumatic bleeding, central nervous system hemorrhage, pulmonary hemorrhage

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock, Cardiogenic

Intervention

Procedure:
• Early left atrial septostomy within 12 hours after VA-ECMO implantation
Early left atrial septostomy group will routinely receive left atrial septostomy within 12 hours after VA-ECMO implantation. Left atrial septostomy will be done using percutaneous technique.
• Selective left atrial septostomy
Left atrial septostomy will be done in cases of deleterious effect of increased LVEDP after VA-ECMO implantation, such as refractory pulmonary edema, abnormal opening of aortic valve, left ventricular dilatation, refractory ventricular tachycardia or fibrillation.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence rate of all-cause death	Cumulative incidence rate of all-cause death	Up to 30 days
Secondary	Rate of all-cause death or left atrial septostomy in conventional approach group	Rate of all-cause death or left atrial septostomy in conventional approach group	Up to 30 days
Secondary	Rate of left atrial septostomy in conventional approach group	Rate of left atrial septostomy in conventional approach group	Up to 30 days
Secondary	Incidence rate of all-cause death during index admission	Incidence rate of all-cause death during index admission	Up to 6 months
Secondary	Cumulative incidence rate of cardiac death	Cumulative incidence rate of cardiac death	Up to 30 days
Secondary	Cumulative incidence rate of non-cardiac death	Cumulative incidence rate of non-cardiac death	Up to 30 days
Secondary	Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission	Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission	Up to 6 months
Secondary	Rate of disappearance of pulmonary edema on chest X-ray during index admission	Rate of disappearance of pulmonary edema on chest X-ray during index admission	Up to 6 months
Secondary	Weaning rate from mechanical ventilator during index admission	Weaning rate from mechanical ventilator during index admission	Up to 6 months
Secondary	Intensive care unit length of stay during index admission	Intensive care unit length of stay during index admission	Up to 6 months
Secondary	Hospital length of stay	Hospital length of stay	Up to 6 months
Secondary	Lactate normalization rate	Lactate normalization rate	Up to 30 days
Secondary	Lactate clearance rate	Lactate clearance rate	Up to 30 days
Secondary	Rate of renal replacement therapy during index admission	Rate of renal replacement therapy during index admission	Up to 6 months
Secondary	Rate of limb ischemia during index admission	Rate of limb ischemia during index admission	Up to 6 months
Secondary	Rate of infection during index admission	Rate of infection during index admission	Up to 6 months
Secondary	Rate of transient ischemic attack or stroke during index admission	Rate of transient ischemic attack or stroke during index admission	Up to 6 months
Secondary	Rate of BARC bleeding type 3 or 5 during index admission	Rate of BARC bleeding type 3 or 5 during index admission	Up to 6 months
Secondary	Rate of bridge to ventricular assist device or heart transplantation during index admission	Rate of bridge to ventricular assist device or heart transplantation during index admission	Up to 6 months
Secondary	Rate of major vascular injury or cardiac tamponade during left atrial septostomy	Rate of major vascular injury or cardiac tamponade during left atrial septostomy	Up to 30 days
Secondary	Cumulative incidence rate of all-cause death	Cumulative incidence rate of all-cause death	Up to 12 months
Secondary	Cumulative incidence rate of cardiac death	Cumulative incidence rate of cardiac death	Up to 12 months
Secondary	Cumulative incidence rate of non-cardiac death	Cumulative incidence rate of non-cardiac death	Up to 12 months
Secondary	Re-hospitalization rate due to heart failure	Re-hospitalization rate due to heart failure	Up to 12 months
Secondary	All-cause death or re-hospitalization rate due to heart failure	All-cause death or re-hospitalization rate due to heart failure	Up to 12 months