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French Observatory on the Management of Cardiogenic Shock in 2016

French Observatory on the Management of Cardiogenic Shock in 2016

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02703038
Acronym
FRENSHOCK
Enrollment
777
Registered
2016-03-09
Start date
2016-04-30
Completion date
2018-07-31
Last updated
2019-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock, Cardiogenic

Keywords

cardiogenic shock, observatory

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.

Interventions

None listed

Sponsors

French Cardiology Society
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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); * Right Swan Ganz catheterization or (pulmonary capillary pressures\> 15mmHg and / or mPAP\> 25mmHg) (C) Organs malperfusion (1 criterion necessary and sufficient): * Clinic: oliguria \<30ml / kg / h, mottling, consciousness disorders) * Organic: arterial lactate\> 2 mmol / L, liver failure, kidney failure

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality at day 3030 daysDeath rate at 30 days of follow-up

Secondary

MeasureTime frameDescription
Analysis of mortality at day 30 by subgroup on age, sex, NYHA grade, initial etiology30 daysRate of mortality at day 30 distributed by subgroup on age, sex, NYHA grade, initial etiology (Including ischemic versus non-ischemic heart disease, type and assistance and medical treatment)
Mortality at 1 year1 yearDeath rate at 1 year of follow-up

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026