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

NCT02899897 | Completed

• 1 other identifier: RNI2015-37 Dr Zogheib
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shock, Septic; Ventricular Dysfunction, Left

Keywords

echocardiography

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

echocardiography in IV fluid therapy DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with septic shock.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Shock, Septic; Ventricular Dysfunction, Left

Interventions

Echocardiography; Fluid Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Drug Therapy; Therapeutics

Study Officials

• Elie ZOGHEIB, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 14, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

FR (1)