Trials / Recruiting
RecruitingNCT06862700
Effect of Reduced Vasopressors on Mortality in ECMO-supported Cardiogenic Shock Patients
Association Between Vasopressor Exposure Levels and 30-Day Mortality in Patients Receiving ECMO Support for Cardiogenic Shock: A Prospective Multicenter Cohort Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 534 (estimated)
- Sponsor
- Xiaotong Hou · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cardiogenic Shock
- Extracorporeal Membrane Oxygenation
- Vasopressors
- Hemodynamic Management
- Critical Care
- Heart Failure
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-02-26
- Primary completion
- 2027-01-01
- Completion
- 2028-01-01
- First posted
- 2025-03-06
- Last updated
- 2025-03-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06862700. Inclusion in this directory is not an endorsement.