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NCT Number: NCT06862700

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

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.

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Critical Care Extracorporeal Membrane Oxygenation Heart Diseases Heart Failure Hemodynamic Management Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases Vasopressors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Xiaotong Hou, MD

PRINCIPAL_INVESTIGATOR

Zhongtao Du, MD

CONTACT

[email protected]

86-18610846901

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vasopressor Exposure Levels

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.

Other names: Vasoactive-Inotropic Score (VIS)

Primary outcomes

  1. 30-Day All-Cause Mortality

    Time frame: 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 outcomes

  1. In-Hospital Survival Rate

    Time frame: From ECMO initiation through hospital discharge (assessed up to 6 months).

    The proportion of patients who survive to hospital discharge.

  2. ECMO-Related Complications

    Time frame: From ECMO initiation through hospital discharge (assessed up to 6 months).

    The incidence of ECMO-related complications, including bleeding, thrombosis, infection, and mechanical failures.

Study contacts

Contact information is provided by the study sponsor or research team.

Chenglong Li, MD

CONTACT

[email protected]

86-18610846901

Xiaotong Hou, MD

CONTACT

[email protected]

010-64456631

Sponsors and collaborators

Lead sponsor

Xiaotong Hou

Other

Registry information

Official study title

Association Between Vasopressor Exposure Levels and 30-Day Mortality in Patients Receiving ECMO Support for Cardiogenic Shock: A Prospective Multicenter Cohort Study

Acronym: VREM-CS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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