Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation

N/ANot Yet RecruitingNCT06872021

Beijing Anzhen Hospital358 enrolled

Overview

The goal of this multicenter, randomized trial is to compare early early left ventricular unloading by Intra-aortic Balloon Pump (IABP) versus conventional approach in patients with cardiogenic shock (CS) undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). The main question it aims to answer is : • If left ventricular unloading by IABP as compared with the conventional approach will improve the outcomes in patients undergoing VA-ECMO.

The role of IABP combined with VA-ECMO in patients with CS remains unclear. Therefore, investigators will conduct a prospective randomized clinical trial to explore the effect of early IABP use for LV unloading after VA-ECMO on outcomes in patients with CS. Investigators will randomly assign 358 patients receiving peripheral VA-ECMO to the ECMO+IABP group (n=179) or the ECMO group (n=179). The primary end point was the 30-day mortality.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

358

Conditions

ECMO

Interventions

Early IABP useOTHER

Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.

Conventional approachOTHER

Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age of ≥18 2. Cardiogenic shock(defined as a systolic blood pressure of less than 90 mm Hg for more than 30 minutes or the initiation of catecholamines to maintain a systolic pressure of more than 90 mm Hg, an arterial lactate level of more than 3 mmol per liter, and signs of impaired organ perfusion) 3. Successful implantation of VA-ECMO 4. Informed consent Exclusion Criteria: 1. Presence of moderate to severe aortic insufficiency or aortic dissection 2. Severe peripheral vascular disease 3. Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure. 4. VA-ECMO for definite non-cardiac causes 5. Extracorporeal cardiopulmonary resuscitation 6. Implantation of IABP or IMPELLA before VA-ECMO 7. Severe bleeding 8. Terminal malignancy 9. Irreversible neurologic injury 10. Pregnancy or lactation

Locations (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

30-day mortality

Time frame: 30 days

Secondary Outcomes

weaning from VA-ECMO

Time frame: 30 days

Rate of advanced mechanical unloading

Time frame: 30 days

Left Ventricular Function of survivors

Time frame: 30 days

In-hospital Mortality

Time frame: 30 days

Day of Mechanical Circulatory Support Device Weaning

Time frame: 30 days

Rate of pulmonary congestion on chest X-ray

Time frame: 30 days

Duration of VA-ECMO

Time frame: 30 days

Lactate clearance rate at 12 and 24 hours

Time frame: 30 days

Relative decrease in vasoactive inotropic score(VIS) at 12 and 24 hours

Vasoactive inotropic score (VIS), in µg/kg/min, was calculated as follows: dopamine + dobutamine + 100 epinephrine + 100 norepinephrine + 15×milrinone. Higher VIS predict worse outome.

Time frame: 30 days

Reduction in Myocardial Injury Biomarkers (cTnI/cTnT)

Time frame: 30 days

Reduction in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)

Central Contacts

Xiaotong Hou, MD, PhD

CONTACT

010-64456631 xt.hou@ccmu.edu.cn

Data from ClinicalTrials.gov

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