Hemodynamic Instability, Shock, Septic
Conditions
Keywords
Monitoring, Transthoracic Echocardiography, Blood Volume, Fluid management
Brief 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.
Interventions
OTHEREchographic 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
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 * Patient in an intensive care unit who develops septic shock on admission or during hospitalization, as defined by SEPSIS-3 criteria. * Patient or trusted person / legal representative / family member / curator / guardian who has given free and informed consent and has signed the consent form or patient included in an emergency situation. * Patient affiliated or beneficiary of a health insurance plan. * Patient at least (≥) 18 years of age.
Exclusion criteria
* Refusal of consent. * Patient under court protection or guardianship. * Moribund patient with a life expectancy of less than 48 hours. * Non-echogenic patient. * Cardiac tamponade. * Infective endocarditis. * Intracavitary thrombus. * Dilated cardiomyopathy with LVEF (Left Ventricular Ejection Fraction\<40%. * Parturient or nursing patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of vascular filling during the first 4 days | Day 4 | This takes into account the cumulative volume of vascular filling administered to improve cardiac output during the 4 first days, measured in Liter (L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| .Analysis of the primary endpoint related to ARDS ([acute respiratory distress syndrome, according to Berlin criteria) | Day 4 | Analysis of the primary endpoint in relation with presence or absence of ARDS at inclusion |
| Analysis of the primary endpoint related to severe renal dysfunction | Day 4 | Analysis of the primary endpoint in relation with severe renal dysfunction defined as a KDIGO (Kidney Disease Improving Global Outcomes) score ≥3 vs \<3. |
| Analysis of the primary endpoint in relation with patient severity | Day 4 | Analysis of the primary endpoint in relation withpatient severity according to SAPS 2 (Simplified Acute Physiology Score) score: \<15, 15-30, \>30 |
| Mortality | Day 28 | Patient deceased: yes or no |
| Number of days alive without failure at Day 28 | Day 28 | Number of days without failure |
| Time to normalization of lactatemia (<2 mmol/l) | Day 4 | Represents time from randomization to first lactatemia \<2 mmol/l in hours |
| Fluid balance in L | Day 4 | The fluid balance will be deduced from the daily weight changes in kilograms, the density of water being equal to 1 |
| Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics | Day 4 | Number of therapeutic adjustments |
| Length of stay in ICU (ready for discharge) | Day 28 | Length of stay in ICU from randomization to discharge in days |
| Length of stay in hospital | Day 28 | Number |
| Adverse effects | Day 28 | Number and type of adverse events |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORClaire Roger
CHU Nimes
Outcome results
None listed