Reversibility of Diastolic Disfunction in Septic Shock

• Conditions: Diastolic Dysfunction; Septic Shock

• 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

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Status Verified: 2018-03
• Study Start: 2018-03-01
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-06
• Primary Completion: 2019-01-01
• Study Completion: 2019-04-01

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

Primary Outcome Measures

Name	Time	Method
Mortality at 90 days	90 days	Dead at 90 days

Secondary Outcome Measures

Name	Time	Method
ICU mortality	90 days	Dead in ICU
In hospital mortality	90 days	Dead in hospital
Change in incidence of diastolic dysfunction	From 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 disfunction	During the first 24 hours of ICU admission	According to the criteria specified at groups section

Trial Locations

Locations (4)

Hospital Verge de la Cinta; 🇪🇸 Tortosa, Tarragona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital del Vall d´Hebron; 🇪🇸 Barcelona, Spain