Effect of Reduced Vasopressors on Mortality in ECMO-supported Cardiogenic Shock Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vasopressor Exposure Levels.
- Who it may be relevant to
- Registry conditions: Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Vasopressors, Hemodynamic Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association Between Vasopressor Exposure Levels and 30-Day Mortality in Patients Receiving ECMO Support for Cardiogenic Shock: A Prospective Multicenter Cohort Study
Overview
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.
Detailed 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.
Interventions
- Other Vasopressor Exposure Levels
This is an observational study with no active intervention. The study evaluates the association between natural variations in vasopressor exposure levels (measured by Vasoactive-Inotropic Score, VIS) and clinical outcomes in patients receiving VA-ECMO for cardiogenic shock.
Primary outcome measures
- 30-Day All-Cause Mortality [Time frame: From ECMO initiation through hospital discharge (assessed up to 6 months).]
Secondary outcome measures (2)
- In-Hospital Survival Rate [Time frame: From ECMO initiation through hospital discharge (assessed up to 6 months).]
- ECMO-Related Complications [Time frame: From ECMO initiation through hospital discharge (assessed up to 6 months).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Anzhen Hospital — Beijing
Identifiers
NCT: NCT06862700 · 2025038x