Place of Echocardiography in IV Fluid Therapy in Patients With Septic Shock and Left Ventricular Systolic Dysfunction

Shock, Septic Clinical Trial

— DYSPRED  

Official title:

Place of Echocardiography in IV Fluid Therapy in Patients With Septic Shock and Left Ventricular Systolic Dysfunction: a Multicentre Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899897
• Other study ID #: RNI2015-37 Dr Zogheib
• Status: Completed
• Start date: January 2016
• Est. completion date: September 2018

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

IV fluid therapy remains an essential haemodynamic objective in the treatment strategy of septic shock. Left ventricular systolic dysfunction secondary to sepsis is observed in 40% and up to 65% of the population concerned. However, the capacity of the various indices to predict the response to IV fluid therapy in septic shock with left ventricular systolic dysfunction have not been clearly defined. Measurement of parameters reflecting filling pressures during transthoracic echocardiography (TTE) is one of the methods used to evaluate cardiac function and estimate the filling reserve, but with no strong evidence. Right heart catheterization with determination of cardiac output by pulmonary thermodilution can also be used to measure the various parameters commonly used to predict the response to IV fluid therapy. Very few data are available with no reliable and clinically relevant data in this population with septic shock and left ventricular systolic dysfunction (LVEF ≤ 40%) and the response to IV fluid therapy monitored by dynamic indices obtained by transpulmonary thermodilution and right heart catheterization. Consequently, the capacity of the various indices of preload dependence to predict the response to IV fluid therapy in septic shock with left ventricular systolic dysfunction remains difficult to define.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Septic shock with cardiovascular dysfunction despite norepinephrine,

• Left ventricular systolic dysfunction defined by transthoracic echocardiography and LVEF = 40%

• Fluid challenge decided by the patient's attending physician according to the optimization of cardiac output in septic shock protocol,

• IV fluid therapy with 500 ml of crystalloid solution.

• Haemodynamic monitoring decided by the patient's referring physician not involved in the study, according to the department's usual practice by transthoracic echocardiography and thermodilution monitoring.

• Sedated, on mechanical ventilation, and adapted to the ventilator.

• Patients who have received oral information and written documentation (with a copy filed in the medical records) on awakening.

• The trusted person designated for each patient has received the same oral and written information.

Exclusion Criteria:

Patients under the age of 18 years, pregnant women, patients under judicial protection or deprived of their freedom, Amputation of one or both lower limbs Contraindication to passive leg raising (e.g.: severe IC, etc.), Cardiac tamponade or aortic dissection with uncontrolled active bleeding. No indication for IV fluid therapy

Related Conditions & MeSH terms

• Shock
• Shock, Septic
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• echocardiography in IV fluid therapy

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to IV fluid therapy	defined by an increase in stroke volume by more than 15% of its baseline value measured by thermodilution.	90 minutes