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

NCT06862700 | Recruiting

• 1 other identifier: 2025038x
• Study Type: observational
• Target: 534
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 30-Day All-Cause Mortality

  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 Outcomes (2)

• In-Hospital Survival Rate

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

• ECMO-Related Complications

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

Study Arms (2)

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

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

Interventions

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.

Also known as: Vasoactive-Inotropic Score (VIS)

High VIS Group; Low VIS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults (≥18 years) with cardiogenic shock requiring VA-ECMO support.
• First-time ECMO initiation.
• Venoarterial ECMO (VA-ECMO) as the initial mode.

You may not qualify if:

• Age \<18 years.
• Severe pulmonary hypertension.
• Vasopressor use for non-shock indications (e.g., bleeding, post-cardiopulmonary bypass vasoplegia).
• Severe missing data.

Sponsors & Collaborators

• Xiaotong Hou: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Zhongtao Du, MD

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Xiaotong Hou, MD

CONTACT

010-64456631; xt.hou@ccmu.edu.cn

Chenglong Li, MD

CONTACT

86-18610846901; cl_lee@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 6, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)