Strain Echocardiography During Septic Shock : an Observational Pilot Study

Completed

• Conditions: Shock, Septic; Echocardiography

• Registration Number: NCT03663192
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-22
• Primary Completion: 2018-03-30
• Study First Submitted: 2018-04-05
• Study Completion: 2018-04-30
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain	up to 90 days

Secondary Outcome Measures

Name	Time	Method
ICU mortality	up to 90 days	On the day of patient discharge from the ICU

Trial Locations

Locations (1)

Intensive care unit CHU Nimes; 🇫🇷 Nîmes, France