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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High VIS Group | High VIS Group: Patients with an average Vasoactive-Inotropic Score (VIS) >10 from 12 hours post-ECMO initiation to weaning. |
| |
| Low VIS Group | Low VIS Group: Patients with an average Vasoactive-Inotropic Score (VIS) ≤10 from 12 hours post-ECMO initiation to weaning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| In-Hospital Survival Rate | The proportion of patients who survive to hospital discharge. | From ECMO initiation through hospital discharge (assessed up to 6 months). |
| ECMO-Related Complications |
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Inclusion Criteria:
Exclusion Criteria:
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At participating centers, adult patients with cardiogenic shock require venoarterial extracorporeal membrane oxygenation (VA-ECMO) support, meeting specific hemodynamic and end-organ dysfunction criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaotong Hou, MD | Contact | 010-64456631 | xt.hou@ccmu.edu.cn | |
| Chenglong Li, MD | Contact | 86-18610846901 | cl_lee@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhongtao Du, MD | Beijing Anzhen Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
The incidence of ECMO-related complications, including bleeding, thrombosis, infection, and mechanical failures.
| From ECMO initiation through hospital discharge (assessed up to 6 months). |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |