Effect of Reduced Vasopressors on Mortality in ECMO-supported Cardiogenic Shock Patients (VREM-CS)

Xiaotong Hou

Status: Enrolling

Conditions: Vasopressors; Critical Care; Hemodynamic Management; Heart Failure; Cardiogenic Shock; Extracorporeal Membrane Oxygenation

Treatments: Other: Vasopressor Exposure Levels

Study type: Observational

Funder types: Other

Identifiers

NCT06862700

2025038x

Details and patient eligibility

About

The goal of this observational study is to learn about the association between vasopressor exposure levels and outcomes in adults with cardiogenic shock receiving VA-ECMO. The main question it aims to answer is:

Does reduced exposure to vasopressors lower the 30-day mortality in patients with cardiogenic shock when receiving ECMO support? Participants who are receiving ECMO support for cardiogenic shock as part of their regular medical care will have their data collected, including information about their vasopressor use and mortality outcomes, over the course of the study.

Full description

The study will enroll 534 patients from multiple centers who require VA-ECMO for cardiogenic shock. Patients will be stratified into two groups based on their average Vasoactive-Inotropic Score (VIS) from 12 hours post-ECMO initiation to weaning: a high-dose group (VIS >10) and a low-dose group (VIS ≤10). The primary outcome is 30-day all-cause mortality. Secondary outcomes include hospital survival rate, duration of mechanical ventilation, ICU and hospital length of stay, and ECMO-related complications. Hemodynamic parameters and laboratory biomarkers will be monitored. The study aims to identify optimal hemodynamic management strategies, including ECMO flow rates, blood pressure targets, and vasopressor dosing, to improve patient outcomes.

Enrollment: 534 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥18 years) with cardiogenic shock requiring VA-ECMO support.
• First-time ECMO initiation.
• Venoarterial ECMO (VA-ECMO) as the initial mode.

Exclusion criteria

• Age <18 years.
• Severe pulmonary hypertension.
• Vasopressor use for non-shock indications (e.g., bleeding, post-cardiopulmonary bypass vasoplegia).
• Severe missing data.

Trial design

534 participants in 2 patient groups

High VIS Group

Description:

High VIS Group: Patients with an average Vasoactive-Inotropic Score (VIS) \>10 from 12 hours post-ECMO initiation to weaning.

Treatment:

Other: Vasopressor Exposure Levels

Low VIS Group

Description:

Low VIS Group: Patients with an average Vasoactive-Inotropic Score (VIS) ≤10 from 12 hours post-ECMO initiation to weaning.

Treatment:

Other: Vasopressor Exposure Levels