Clinical trial NCT06862700: Effect of Reduced Vasopressors on Mortality in ECMO-supported Cardiogenic Shock Patients
Official title: Association Between Vasopressor Exposure Levels and 30-Day Mortality in Patients Receiving ECMO Support for Cardiogenic Shock: A Prospective Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Extracorporeal Membrane Oxygenation
Vasopressors
Hemodynamic Management
Critical Care
Heart Failure
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At participating centers, adult patients with cardiogenic shock require venoarterial extracorporeal membrane oxygenation (VA-ECMO) support, meeting specific hemodynamic and end-organ dysfunction criteria.

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.

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.

Primary outcomes:
measure: 30-Day All-Cause Mortality
timeFrame: From ECMO initiation through hospital discharge (assessed up to 6 months).
Secondary outcomes:
measure: In-Hospital Survival Rate
timeFrame: From ECMO initiation through hospital discharge (assessed up to 6 months).
measure: ECMO-Related Complications
timeFrame: From ECMO initiation through hospital discharge (assessed up to 6 months).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Zhongtao Du, MD
role: STUDY_CHAIR
References: