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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05838937
Other study ID # BMEÜ/4229- 1 /2022/EKU
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date December 1, 2025

Study information

Verified date April 2024
Source Semmelweis University Heart and Vascular Center
Contact Bálint K Lakatos, MD, PhD
Phone +36306663540
Email lakatos.balint@med.semmelweis-univ.hu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.


Description:

The study aims to examine the prognostic role of non-invasive myocardial work in veno-arterial extracorporeal membrane oxygenation therapy patients. Subjects with cardiogenic shock regardless of etiology will be enrolled 48-72 hours after the initiation of mechanical circulatory support. It is hypothesized that non-invasive myocardial work may be an independent prognosticator of the outcome.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - 18 years or older age - Severe cardiogenic shock requiring the initiation of VA-ECMO therapy - Stabile hemodynamic state and oxigenation with VA-ECMO and vasoactive support - Informed written consent (due to the nature of the study, from a legally eligible relative of the patient) Exclusion Criteria: - Younger than 18 years of age - Unstable hemodynamic state or suboptimal oxigenation despite established VA-ECMO and vasoactive support - Severe neurological damage or confirmed brain death at the time of enrollment which squarely indicates therapy limitation and poor short-term outcome - Transesophageal echocardiography is contraindicated - Suboptimal echocardiographic window

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Hungary Semmelweis University Heart and Vascular Center Budapest BP

Sponsors (3)

Lead Sponsor Collaborator
Semmelweis University Heart and Vascular Center I.Medizinische Klinik, Universitätsklinikum Mannheim, University Hospital, Limoges

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation The total number of patients who die from cardiovascular cause, or require for transition to long-term mechanical circulatory support (LVAD/BiVAD), or heart transplantation 30 days
Secondary All-cause mortality Death from any cause during the study period 30 days
Secondary Need for renal replacement therapy The total number of patients who need for renal replacement therapy during intensive care 30 days
Secondary Successful weaning from mechanical ventilation The total number of patients who can be successfully weaned from invasive mechanical ventilation 30 days
Secondary Discharge from intensive care unit The total number of patients who are discharged from intensive care unit 30 days
Secondary Discharge from hospital The total number of patients who are discharged from hospital 30 days
Secondary Ventilator-free days Days spent without invasive mechanical ventilation 30 days
Secondary VA-ECMO-free days Days spent without VA-ECMO support 30 days
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