An interventional study of Echographic hemodynamic algorithm guiding fluid resuscitation in Shock, Septic and Hemodynamic Instability, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Other
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 136 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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All eligible patients will have a cardiac echocardiogram prior to inclusion for the sole purpose of eliminating special situations that are part of the non-inclusion criteria listed below.
Inclusion Criteria
Exclusion Criteria:
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.
Other: Echographic hemodynamic algorithm guiding fluid resuscitation
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)
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
Volume of vascular filling during the first 4 days
This takes into account the cumulative volume of vascular filling administered to improve cardiac output during the 4 first days, measured in Liter (L)
Time frame: Day 4
.Analysis of the primary endpoint related to ARDS ([acute respiratory distress syndrome, according to Berlin criteria)
Analysis of the primary endpoint in relation with presence or absence of ARDS at inclusion
Time frame: Day 4
Analysis of the primary endpoint related to severe renal dysfunction
Analysis of the primary endpoint in relation with severe renal dysfunction defined as a KDIGO (Kidney Disease Improving Global Outcomes) score ≥3 vs \<3.
Time frame: Day 4
Analysis of the primary endpoint in relation with patient severity
Analysis of the primary endpoint in relation withpatient severity according to SAPS 2 (Simplified Acute Physiology Score) score: \<15, 15-30, \>30
Time frame: Day 4
Mortality
Patient deceased: yes or no
Time frame: Day 28
Number of days alive without failure at Day 28
Number of days without failure
Time frame: Day 28
Time to normalization of lactatemia (<2 mmol/l)
Represents time from randomization to first lactatemia \<2 mmol/l in hours
Time frame: Day 4
Fluid balance in L
The fluid balance will be deduced from the daily weight changes in kilograms, the density of water being equal to 1
Time frame: Day 4
Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics
Number of therapeutic adjustments
Time frame: Day 4
Length of stay in ICU (ready for discharge)
Length of stay in ICU from randomization to discharge in days
Time frame: Day 28
Length of stay in hospital
Number
Time frame: Day 28
Adverse effects
Number and type of adverse events
Time frame: Day 28
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes