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Reversibility of Diastolic Disfunction in Septic Shock

Conditions
Diastolic Dysfunction
Septic Shock
Interventions
Diagnostic Test: Echocardiography
Registration Number
NCT03198611
Lead Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Brief Summary

Objectives: To study the prognostic value of the evolution of diastolic function according to fluid balance in patients admitted to the ICU with a diagnosis of septic shock, in terms of mortality (ICU and hospital) and mortality at 90 days.

2.4. Secondary objectives: A) Incidence and reversibility of myocardial dysfunction (left ventricular systolic and diastolic) in septic shock.

B) Incidence and reversibility of diastolic dysfunction according to the echocardiographic criterion used.

C) Incidence and reversibility of right ventricular systolic dysfunction.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
350
Inclusion Criteria
  • Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h
Exclusion Criteria
  • No echocardiographic window
  • Fatal prognosis with do not resuscitate orders at admission
  • Previous history of Ischemic cardiomyopathy
  • Valvular prosthesis
  • Advanced degree of valvular disorder
  • Advanced degree of pericardial effusion

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Left ventricular diastolic dysfunctionEchocardiographyClassification according to: * Mitral lateral annulus e' in tissue Doppler \< 10 cm/s * American society of echocardiography (ASE) criteria 2009 * ASE criteria 2016
Left ventricular systolic dysfunctionEchocardiographyLeft ventricular ejection fraction \< 50%
Normal functionEchocardiographyNo systolic dysfunction No diastolic dysfunction No right ventricular dysfunction
Right ventricular dysfunctionEchocardiographyTricuspid annulus plane systolic excursion \< 17 cm
Primary Outcome Measures
NameTimeMethod
Mortality at 90 days90 days

Dead at 90 days

Secondary Outcome Measures
NameTimeMethod
ICU mortality90 days

Dead in ICU

In hospital mortality90 days

Dead in hospital

Change in incidence of diastolic dysfunctionFrom first 24 hours of ICU admission until 48h, 72h and 7 days from admission

Change in incidence of diastolic dysfunction according to the different criteria used.

Incidence of myocardial disfunctionDuring the first 24 hours of ICU admission

According to the criteria specified at groups section

Trial Locations

Locations (4)

Hospital del Mar

🇪🇸

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

🇪🇸

Barcelona, Spain

Hospital del Vall d´Hebron

🇪🇸

Barcelona, Spain

Hospital Verge de la Cinta

🇪🇸

Tortosa, Tarragona, Spain

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