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

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.

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Key information

Conditions

Shock, Septic Cardiovascular Diseases Heart Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Systemic Inflammatory Response Syndrome Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

echocardiography in IV fluid therapy

Device

Primary outcomes

Response to IV fluid therapy

Time frame: 90 minutes

defined by an increase in stroke volume by more than 15% of its baseline value measured by thermodilution.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: DYSPRED

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Sep 14, 2016
Registry last updated: Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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