NCT05752383

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jan 2023Jan 2029

First Submitted

Initial submission to the registry

January 24, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 24, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 2, 2023

Status Verified

January 1, 2023

Enrollment Period

4.9 years

First QC Date

January 24, 2023

Last Update Submit

February 21, 2023

Conditions

Cardiogenic Shock

Keywords

Cardiogenic Shockvaso-inotropic score

Outcome Measures

Primary Outcomes (2)

  • Percentage of in-hospital mortality after cardiogenic shock

    5 years

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Patients hospitalized in ICU for cardiogenic shock * Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria

You may qualify if:

  • Patients hospitalized in ICU for cardiogenic shock
  • Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, France

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Central Study Contacts

Christophe Beyls, MD

CONTACT

03 22 08 78 66beyls.christophe@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2023

First Posted

March 2, 2023

Study Start

January 24, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

March 2, 2023

Record last verified: 2023-01

Locations

FR(1)