Reversibility of Diastolic Disfunction in Septic Shock

Study Overview
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Brief Summary
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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.

Official Title
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Early Reversibility of Diastolic Disfunction as a Prognostic Factor in Septic Shock

Conditions
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Diastolic Dysfunction, Septic Shock

Intervention / Treatment
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* Diagnostic Test: Echocardiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal function<br>No systolic dysfunction No diastolic dysfunction No right ventricular dysfunction | Diagnostic Test: Echocardiography<br>* Usual echocardiographic studies in patients suffering septic shock<br>|
| Left ventricular systolic dysfunction<br>Left ventricular ejection fraction < 50% | Diagnostic Test: Echocardiography<br>* Usual echocardiographic studies in patients suffering septic shock<br>|
| Left ventricular diastolic dysfunction<br>Classification according to: Mitral lateral annulus e' in tissue Doppler < 10 cm/s American society of echocardiography (ASE) criteria 2009 ASE criteria 2016 | Diagnostic Test: Echocardiography<br>* Usual echocardiographic studies in patients suffering septic shock<br>|
| Right ventricular dysfunction<br>Tricuspid annulus plane systolic excursion < 17 cm | Diagnostic Test: Echocardiography<br>* Usual echocardiographic studies in patients suffering septic shock<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at 90 days | Dead at 90 days | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | Dead in ICU | 90 days | 
| In hospital mortality | Dead in hospital | 90 days | 
| Incidence of myocardial disfunction | According to the criteria specified at groups section | During the first 24 hours of ICU admission | 
| Change in incidence of diastolic dysfunction | Change in incidence of diastolic dysfunction according to the different criteria used. | From first 24 hours of ICU admission until 48h, 72h and 7 days from admission |