Clinical trial NCT02703038: French Observatory on the Management of Cardiogenic Shock in 2016
Official title: French Observatory on the Management of Cardiogenic Shock in 2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock, Cardiogenic
Keywords: cardiogenic shock
observatory
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 777
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (\> 18 years) with cardiogenic shock table defined by the combination of a low cardiac output even as the filling pressures are normal or high, originally of hypoperfusion and suffering of organ.

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.

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);
* 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

Primary outcomes:
measure: Mortality at day 30
timeFrame: 30 days
Secondary outcomes:
measure: Analysis of mortality at day 30 by subgroup on age, sex, NYHA grade, initial etiology
timeFrame: 30 days
measure: Mortality at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: AP
name: Clément DELMAS
role: PRINCIPAL_INVESTIGATOR
References:
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