Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients

Recruiting

• Conditions: Septic Shock; Left Ventricular Systolic Dysfunction

• Registration Number: NCT04963686
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-15
• Study Start: 2021-08-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance between GLS and echocardiographic algorithm	3 months	left ventricular global longitudinal strain = GLS The echocardiographic parameters used are: lateral S' wave; septal, lateral and mean MAPSE; and LWFS.
Concordance between LVEF and echocardiographic algorithm	3 months	left ventricular ejection function = LVEF The echocardiographic parameters used are: lateral S' wave; septal, lateral and mean MAPSE; and LWFS.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France