Strain Echocardiography During Septic Shock : an Observational Pilot Study

Echocardiography Clinical Trial

— Sepsistrain  

Official title:

Strain Echocardiography During Septic Shock : an Observational Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663192
• Other study ID #: IRB : 16.02.07
• Status: Completed
• Start date: February 22, 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2018
• Est. primary completion date: March 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Echocardiography
• Shock
• Shock, Septic

Intervention

Device:
• strain echocardiography
strain echocardiography during septic shock

Locations

Country	Name	City	State
France	Intensive care unit CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain		up to 90 days
Secondary	ICU mortality	On the day of patient discharge from the ICU	up to 90 days