Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients

Septic Shock Clinical Trial

— MAPSE  

Official title:

Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963686
• Other study ID #: PI2021_843_0150
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: November 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Michel Slama, Pr
• Phone: 0322089809
• Email: slama.michel[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The assessment of left ventricular systolic function is based on the measurement of left ventricular ejection function (LVEF) by the Simpson biplane method. More recently, left ventricular global longitudinal strain (GLS) has been developed to detect abnormalities of cardiac contractility in patients with preserved myocardial contractility. However, both tools are not always easy to collect in practice. This is why other ultrasound parameters have been proposed in the literature as a substitute for LVEF and GLS such as the Doppler tissue imaging (DTI)-derived mitral annular systolic peak S-wave velocity (S'), the mitral annular plane systolic excursion (MAPSE) and the longitudinal wall fractional shortening index (LWFS).

The purpose of this project is to propose an algorithm using simple parameters (S' wave, lateral MAPSE, septal MAPSE, mean MAPSE and LWFS) to predict LVEF and GLS in order to diagnose patients with impaired systolic function and preserved ejection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients hospitalized in the Medical Intensive Care Department of the Amiens-Picardie University Hospital for the management of septic shock.

• Septic shock is defined by sepsis with a need for vasopressor amines to maintain a mean arterial pressure higher than or equal to 65 mmHg, and associated with hyperlactatemia (higher than 2 mmol/L).

• A transthoracic echocardiography should be performed within 72 hours of the diagnosis of septic shock.

Exclusion Criteria:

• Patient with cardiac arrhythmias,

• patients with severe mitral or aortic valve disease,

• patients with fused mitral Doppler flow,

• patients with insufficient echogenicity to allow a correct assessment of left ventricular systolic function.

Related Conditions & MeSH terms

• Left Ventricular Systolic Dysfunction
• Septic Shock
• Shock
• Shock, Septic
• Systolic Murmurs

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between LVEF and echocardiographic algorithm	left ventricular ejection function = LVEF The echocardiographic parameters used are: lateral S' wave; septal, lateral and mean MAPSE; and LWFS.	3 months
Primary	Concordance between GLS and echocardiographic algorithm	left ventricular global longitudinal strain = GLS The echocardiographic parameters used are: lateral S' wave; septal, lateral and mean MAPSE; and LWFS.	3 months