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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
136
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
CHU de Nimes
Nîmes, France
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.