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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663192
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Shock, Septic Echocardiography Device: strain echocardiography

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Strain Echocardiography During Septic Shock : an Observational Pilot Study
Actual Study Start Date : February 22, 2016
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock


Intervention Details:
  • Device: strain echocardiography
    strain echocardiography during septic shock


Primary Outcome Measures :
  1. Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain [ Time Frame: up to 90 days ]

Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: up to 90 days ]
    On the day of patient discharge from the ICU



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
ICU patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663192


Locations
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France
Intensive care unit CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Claire Roger, MD,PhD CHU Nimes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03663192    
Other Study ID Numbers: IRB : 16.02.07
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Shock, Septic
Echocardiography
speckle tracking
strain
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation