Cardiogenic Shock, Critical Care, Extracorporeal Membrane Oxygenation, Heart Failure, Hemodynamic Management, Vasopressors
Conditions
Brief summary
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
OTHERVasopressor 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.
Sponsors
Xiaotong Hou
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-Day All-Cause Mortality | From ECMO initiation through hospital discharge (assessed up to 6 months). | The proportion of patients who die from any cause within 30 days following ECMO initiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-Hospital Survival Rate | From ECMO initiation through hospital discharge (assessed up to 6 months). | The proportion of patients who survive to hospital discharge. |
| ECMO-Related Complications | From ECMO initiation through hospital discharge (assessed up to 6 months). | The incidence of ECMO-related complications, including bleeding, thrombosis, infection, and mechanical failures. |
Countries
China
Contacts
Primary ContactXiaotong Hou, MD
Backup ContactChenglong Li, MD
Outcome results
None listed