Strain Echocardiography During Septic Shock : an Observational Pilot Study (Sepsistrain)

The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. A decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (LVEF), but a recent meta-analysis did not support such results. In fact, it appears that high LVEF are linked to profound vasoplegia which is associated to bad outcome.

In the other hand, alterations of Strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. Only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. Moreover, the right ventricular strain was reported only by Orde et al whereas the evolution of strain during fluid infusion have never been studied. The aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.

Study Overview

• Status: Completed
• Conditions: Shock, Septic; Echocardiography
• Intervention / Treatment: Device: strain echocardiography

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Intensive care Unit CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU patients

Description

Inclusion Criteria:

• Septic shock (suspected or proven infection and norepinephrine ≥ 0,25µg/kg/min)
• Inclusion within the first 24h of septic shock

Exclusion Criteria:

• Patient < 18 year of age
• Pregnant women
• History of myocardial infarction, valvular disease, atrial fibrillation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain	up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU mortality	On the day of patient discharge from the ICU	up to 90 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Claire Roger, MD,PhD, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2016
• Primary Completion (ACTUAL): March 30, 2018
• Study Completion (ACTUAL): April 30, 2018

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (ACTUAL): September 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Echocardiography; Shock, Septic; speckle tracking; strain
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: IRB : 16.02.07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No