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French Observatory on the Management of Cardiogenic Shock in 2016 (FRENSHOCK)

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ClinicalTrials.gov Identifier: NCT02703038
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society

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.


Condition or disease
Shock, Cardiogenic

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.


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Study Type : Observational
Actual Enrollment : 777 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: French Observatory on the Management of Cardiogenic Shock in 2016
Actual Study Start Date : April 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort
Cardiogenic shock
Patient 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 organ suffering.



Primary Outcome Measures :
  1. Mortality at day 30 [ Time Frame: 30 days ]
    Death rate at 30 days of follow-up


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703038


Locations
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France
CHU Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
French Cardiology Society
Investigators
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Principal Investigator: Clément DELMAS AP

Publications of Results:
Other Publications:

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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT02703038     History of Changes
Other Study ID Numbers: 15897
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by French Cardiology Society:
cardiogenic shock
observatory
Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases