At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Echographic hemodynamic algorithm guiding fluid resuscitation for Shock, Septic and Hemodynamic Instability. Completed, enrolled 136 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Fluid management is optimised using the specific echographic hemodynamic algorithm ('STOPFLUID') of this study described during the first 4 days of septic shock. Fluid bolus will not be administered in case of increased left ventricle filling pressures; fluid challenge will be performed based on dynamic indices and fluid depletion will be considered on the basis of Lung UltraSound (LUS) assessment.
Fluid management will be handled according to standard care, without using transthoracic echocardiography (TTE) during the first 4 days of septic shock management. Haemodynamic monitoring including pulmonary artery catheter, transpulmonary thermodilution, or any other device will be left at the physician's discretion. TTE will be allowed in the standard group only for excluding cardiac tamponade in case of clinical suspicion (one or more of the following signs: jugular distension, pulsus paradoxus)
Interventions
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