Effect of Reduced Vasopressors on Mortality in ECMO-supported Cardiogenic Shock Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

534 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-26

Study Completion Date

2028-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predictors of Mortality in Patients With VA-Extracorporeal Membrane Oxygenation.

NCT05730894

Morality VA-ECMO

UNKNOWN

Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation in Patients Supported by Veino-arterial ECMO for Cardiogenic Shock

NCT04990349

Cardiogenic Shock Extracorporeal Membrane Oxygenation

COMPLETED PHASE3

Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock

NCT07085221

Shock, Cardiogenic Shock

RECRUITING NA

Comparison of Four Intensive Care Scores in Prediction of VA-ECMO Survival.

NCT05730881

Cardiogenic Shock Extracorporeal Membrane Oxygenation Complication

UNKNOWN

Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Under VA ECMO

NCT03327493

Shock, Cardiogenic Extra-Corporeal-Life-Support ( ECLS) Autonomic Nervous System Diseases +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High VIS Group

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

Vasopressor Exposure Levels

Intervention Type OTHER

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.

Low VIS Group

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

Vasopressor Exposure Levels

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vasoactive-Inotropic Score (VIS)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No