Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.

Cardiogenic Shock Clinical Trial

— cardiac shock  

Official title:

Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04467294
• Other study ID #: 2019-29
• Secondary ID: 2019-A01294-53
• Status: Recruiting
• Start date: April 4, 2020
• Est. completion date: October 4, 2023

Study information

• Verified date: July 2020
• Source: Assistance Publique Hopitaux De Marseille
• Contact: bonello laurent
• Phone: 0491968858
• Email: laurent.bonello[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Cardiogenic shock (CC) is one of the major challenges of current cardiology. Despite the difficulty of establishing a strict and consensual definition, it is accepted that the CC clinically corresponds to persistent hypotension (systolic blood pressure 90 mmHg for at least 30 minutes or need for vasopressor support) associated with signs of visceral hypoperfusion (confusion, mottling, oliguria, hyperlactatemia), and hemodynamic with a lowered heart index ( 1.8 L/min/m2) despite appropriate or high filling pressures. This definition of the European Society of Cardiology (ESC) masks however the great variability of hemodynamic tables grouped under the term of CC and severity levels, also variable.However, it was suggested that the etiology of CC influenced both its hemodynamic profile and therefore its therapeutic management but also its prognosis in the medium and long term.

Description:

CC diagnosis remains difficult to carry on admission and is sometimes delayed. Therefore, we would like to compare hemodynamic data from patients with CC status to those admitted for acute heart failure (ICA) to determine if a hemodynamic variable at entry would facilitate the diagnosis of CC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1650
• Est. completion date: October 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients in Cardiac Shock :

• 90 mmHg hypotension or requiring inotropic or vasopressor support,

• owered cardiac output ( 1.8 L/min/m2) to trans-thoracic cardiac ultrasound with high or normal filling pressures

• peripheral hypoperfusion. patients admitted for acute heart failure (ICA) (Acute pulmonary edema chart or left congestive heart failure without CC sign and with ultrasound FEVG at entry 40%.)

Exclusion Criteria:

• Pregnant or nursing women

• Age 18 years

• Person of full age under guardianship

• Staying in a health or social facility

• Person not covered by a social security scheme

• Person deprived of liberty

• Shocks from other etiologies

• Patient with initial cardiac arrest

• Patient with cardiogenic shock due to right ventricular dysfunction

• Patient with pulmonary embolism

• Patient with tamponade

• Refusal to participate

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of Cardiac Shock		12 months
Secondary	mortality		one month
Secondary	mortality		one year