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Completed

NCT Number: NCT02703038

French Observatory on the Management of Cardiogenic Shock in 2016

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Toulouse

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality at day 30

    Time frame: 30 days

    Death rate at 30 days of follow-up

Secondary outcomes

  1. Analysis of mortality at day 30 by subgroup on age, sex, NYHA grade, initial etiology

    Time frame: 30 days

    Rate 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)

  2. Mortality at 1 year

    Time frame: 1 year

    Death rate at 1 year of follow-up

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: FRENSHOCK

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2016
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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