Effect of Reduced Vasopressors on Mortality in ECMO-supported Cardiogenic Shock Patients (VREM-CS)

March 4, 2025 updated by: Xiaotong Hou

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

534

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chenglong Li, MD
  • Phone Number: 86-18610846901
  • Email: cl_lee@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:
        • Principal Investigator:
          • Xiaotong Hou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High VIS Group
High VIS Group: Patients with an average Vasoactive-Inotropic Score (VIS) >10 from 12 hours post-ECMO initiation to weaning.
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.
Other Names:
  • Vasoactive-Inotropic Score (VIS)
Low VIS Group
Low VIS Group: Patients with an average Vasoactive-Inotropic Score (VIS) ≤10 from 12 hours post-ECMO initiation to weaning.
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.
Other Names:
  • Vasoactive-Inotropic Score (VIS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From ECMO initiation through hospital discharge (assessed up to 6 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
The incidence of ECMO-related complications, including bleeding, thrombosis, infection, and mechanical failures.
From ECMO initiation through hospital discharge (assessed up to 6 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaotong Hou

Investigators

  • Study Chair: Zhongtao Du, MD, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025038x

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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