NCT06043505

Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management

Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management: a Multicentric, Randomized, Controlled, Open Label Pilot-study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fluid management is one of the key issues in the initial management of septic shock (SS). Fluid overload and hypovolemia have been associated with increased mortality in several trials. Transthoracic echocardiography (TTE) and lung ultrasound are recommended for haemodynamic assessment in critically ill patients. However, the benefit of hemodynamic optimisation using echography has not been yet evaluated. The purpose of this multicenter, controlled, randomized trial is to assess the impact of an echocardiographic algorithm of hemodynamic optimization on fluid management in septic patients during the first 4 days of therapy.

Conditions

• Shock, Septic
• Hemodynamic Instability

Interventions

Type	Name	Description
OTHER	Echographic hemodynamic algorithm guiding fluid resuscitation	Ultrasound Hemodynamic Algorithm (UHA): 1. st step: 1/ Assessment of left ventricular filling pressures by Mitral Doppler echocardiography (2) 2/ Pulmonary ultrasound on 4 anterior dials (3) E/Ea \>14 and/or E/A \>2 * YES =\> No filling test =\> Bilateral anterior B lines on lung ultrasound =\> YES =\> Consider administration of diuretics * NO =\> Step 2 2. nd step: Assessment of filling response by dynamic maneuvers VTI (Velocity Time Integral) increase \>15% after passive leg raising (4) or Mini-fluid challenge (5,6) Or decision of a 250ml filling test * YES =\> consider 250ml bolus filling * NO =\> stop vascular filling 3. rd step if dynamic maneuvers in favor of a response to filling: 1/ Assessment of response to 250ml filling 2/ If no response to vascular filling: Pulmonary ultrasound on 4 anterior dials (3) Change from a pulmonary profile A to a pulmonary profile B * YES =\> depletion * NO =\> stop vascular filling

Timeline

• Start date: 2024-02-08
• Primary completion: 2024-09-26
• Completion: 2024-10-26
• First posted: 2023-09-21
• Last updated: 2024-03-15

Locations

1 site across 1 country: France