NCT03663192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
Last Updated

December 1, 2025

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

April 5, 2018

Last Update Submit

November 24, 2025

Conditions

Keywords

Shock, SepticEchocardiographyspeckle trackingstrain

Outcome Measures

Primary Outcomes (1)

  • Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain

    up to 90 days

Secondary Outcomes (1)

  • ICU mortality

    up to 90 days

Interventions

strain echocardiography during septic shock

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients

You may qualify if:

  • Septic shock (suspected or proven infection and norepinephrine ≥ 0,25µg/kg/min)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive care unit CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • Bazalgette F, Roger C, Louart B, Daurat A, Bobbia X, Lefrant JY, Muller L. Prognostic value and time course evolution left ventricular global longitudinal strain in septic shock: an exploratory prospective study. J Clin Monit Comput. 2021 Dec;35(6):1501-1510. doi: 10.1007/s10877-020-00620-w. Epub 2020 Nov 20.

MeSH Terms

Conditions

Shock, SepticSprains and Strains

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockWounds and Injuries

Study Officials

  • Claire Roger, MD,PhD

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

September 10, 2018

Study Start

February 22, 2016

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

December 1, 2025

Record last verified: 2019-05

Locations