French Observatory on the Management of Cardiogenic Shock in 2016

Completed

• Conditions: Shock, Cardiogenic

• Registration Number: NCT02703038
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-09
• Study Start: 2016-04
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 777

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality at day 30	30 days	Death rate at 30 days of follow-up

Secondary Outcome Measures

Name	Time	Method
Analysis of mortality at day 30 by subgroup on age, sex, NYHA grade, initial etiology	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)
Mortality at 1 year	1 year	Death rate at 1 year of follow-up

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France