The Clinical and Hemodynamic Course of Cardiogenic Shocks Hospitalized in Critical Care

Cardiogenic Shock Clinical Trial

— HEMOCARD  

Official title:

The Clinical and Hemodynamic Course of Cardiogenic Shocks Hospitalized in Critical Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752383
• Other study ID #: PI2022_843_0132
• Status: Recruiting
• Start date: January 24, 2023
• Est. completion date: January 2029

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Christophe Beyls, MD
• Phone: 03 22 08 78 66
• Email: beyls.christophe[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cardiogenic shock is a frequent reason for hospitalization in critical care units, with high mortality (50%). Several French registries have been created to improve knowledge of the prognostic factors of cardiogenic shock. In recent years, temporary mechanical circulatory support has become more important in cardiogenic shock. The monitoring of catecholamines is also performed with a global score: the vaso-inotropic score. The purpose of our study is to consider using these new data and techniques to create a cohort of cardiogenic shock within our critical care unit.

This observational study is based on clinical, biological, and hemodynamic data recorded during the ICU stay of patients for cardiogenic shock.

The primary endpoint is the relationship between the hemodynamic evolution of cardiogenic shock and in-hospital mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2029
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients hospitalized in ICU for cardiogenic shock

• Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria

Exclusion Criteria:

• Patient with cardiogenic shock in the context of septic shock and hemorrhagic shock

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of in-hospital mortality after cardiogenic shock		5 years
Primary	Vaso-inotropic score after cardiogenic shock	vasoactive-inotropic score (VIS) Maximal VIS (VISmax) is calculated using the highest doses of vasoactive and inotropic medications administered.; VISmax categories: 0-5, >5-15, >15-30, >30-45, and >45 points.	5 years