Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management
- Conditions
- Hemodynamic InstabilityShock, Septic
- Registration Number
- NCT06043505
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 136
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
Time to normalization of lactatemia (<2 mmol/l) Day 4 Represents time from randomization to first lactatemia \<2 mmol/l in hours
Number of days alive without failure at Day 28 Day 28 Number of days without failure
Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics Day 4 Number of therapeutic adjustments
Adverse effects Day 28 Number and type of adverse events
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
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
Trial Locations
- Locations (1)
CHU de Nimes
🇫🇷Nîmes, France
CHU de Nimes🇫🇷Nîmes, FranceAnissa MegzariContactdrc@chu-nimes.frClaire Pr ROGER, MD, PhDPrincipal InvestigatorLaurent Pr MULLER, MD, PhDSub InvestigatorDorian Dr DIDIER LECENE, MDSub Investigator