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Clinical Trials/NCT02703038
NCT02703038
Completed
N/A

French Observatory on the Management of Cardiogenic Shock in 2016

French Cardiology Society1 site in 1 country777 target enrollmentApril 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Shock, Cardiogenic
Sponsor
French Cardiology Society
Enrollment
777
Locations
1
Primary Endpoint
Mortality at day 30
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Cardiogenic shock (CS) is defined as an organ hypoperfusion secondary to low cardiac output. Catches diagnostic management, and therapeutic monitoring of these patients remain highly variable from one center to another and even from one doctor to another within the same team. The management protocols are often not standardized or non-existent.

It appears therefore necessary to make an inventory of the management practices of the CS in France in 2016, prerequisite to a common work of standardization of practices and the creation of specialized networks to support these complex patients.

Detailed Description

The Observatory FRENSHOCK proposes to set up a cohort of 500 patients recruited prospectively over a period of 6 months. Patients will be followed up at 1 month and 1 year Patients should have agreed to participate in the observatory, knowing that participation or refusal to participate will not alter the therapeutic attitude of the physician responsible for the patient. The study of phenotypic characteristics will not change the therapeutic approach of the medical teams.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
July 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
French Cardiology Society
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Informed consent
  • Cardiogenic shock authenticated by the existence of at least one positive test for each of the following three parts:
  • (A) Low cardiac output (1 criterion necessary and sufficient):
  • Clinic: SBP \<90mmHg and / or need to maintain inotropic or vasopressor to maintain SBP\> 90 mmHg
  • Echocardiography: IC \<2.2L / min / m2 and / or LVEF \<30%
  • Hemodynamics by Swan Ganz catheterization or right: IC 2.2 l / min / m2 (B) elevation of pulmonary pressure / left surcharge (1 criterion necessary and sufficient):
  • Clinical (IVD and abortion);
  • Radiological (Surcharge on RT or chest CT);
  • Organic (NTproBNP\> 900pg / ml or BNP\> 400pg / ml);
  • Echocardiography (E / A\> 2 if LVEF \<45% or E / Ea\> 13 if normal LVEF, or PAPS\> 35mmHg and / or TDE \<150ms and / or Ap-Am\> 30ms and / or E / 2 Vp≥ , 5);

Exclusion Criteria

  • Final diagnosis retained other than cardiogenic shock
  • Cardiac arrest without spontaneous activity in the hospital management
  • Post-cardiotomy cardiogenic shock
  • Deprived of liberty patient
  • Refusal or lack of consent

Outcomes

Primary Outcomes

Mortality at day 30

Time Frame: 30 days

Death rate at 30 days of follow-up

Secondary Outcomes

  • Analysis of mortality at day 30 by subgroup on age, sex, NYHA grade, initial etiology(30 days)
  • Mortality at 1 year(1 year)

Study Sites (1)

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