Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients

NCT04963686 | Unknown

• 1 other identifier: PI2021_843_0150
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Systolic Dysfunction; Septic Shock

Keywords

Left ventricular systolic function; global longitudinal strain; Septic Shock

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in the Medical Intensive Care Department of the Amiens-Picardie University Hospital for the management of septic shock. Patient with a transthoracic echocardiography should be performed within 72 hours of the diagnosis of septic shock.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Shock, Septic

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Michel Slama, Pr

CONTACT

0322089809; slama.michel@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 15, 2021
• Study Start: August 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)