The Clinical and Hemodynamic Course of Cardiogenic Shocks... | NCT05752383

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

NCT05752383

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Recruiting

Last Update Posted

Mar 2, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cardiogenic Shock

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 24, 2023Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

Jan 24, 2023

First Submission Date that Met QC Criteria

Feb 21, 2023

First Posted Date

Mar 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2023

Last Update Posted Date

Mar 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christophe Beyls, MD	Contact	03 22 08 78 66		beyls.christophe@chu-amiens.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens Picardie	Recruiting	Amiens			France

Condition Browse Module

MeSH Terms

ID	Term
D012770	Shock, Cardiogenic

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided