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Reversibility of Diastolic Disfunction in Septic Shock (REPRISS)

F

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Unknown

Conditions

Diastolic Dysfunction
Septic Shock

Treatments

Diagnostic Test: Echocardiography

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT03198611
IIBSP-REP-2017-30

Details and patient eligibility

About

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.

Enrollment

350 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

350 participants in 4 patient groups

Normal function
Description:
No systolic dysfunction No diastolic dysfunction No right ventricular dysfunction
Treatment:
Diagnostic Test: Echocardiography
Left ventricular systolic dysfunction
Description:
Left ventricular ejection fraction \< 50%
Treatment:
Diagnostic Test: Echocardiography
Left ventricular diastolic dysfunction
Description:
Classification according to: * Mitral lateral annulus e' in tissue Doppler \< 10 cm/s * American society of echocardiography (ASE) criteria 2009 * ASE criteria 2016
Treatment:
Diagnostic Test: Echocardiography
Right ventricular dysfunction
Description:
Tricuspid annulus plane systolic excursion \< 17 cm
Treatment:
Diagnostic Test: Echocardiography

Trial contacts and locations

5

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Central trial contact

Luis Zapata Fenor, MD PhD

Data sourced from clinicaltrials.gov

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