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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Shock, Septic
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Volume of vascular filling during the first 4 days
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Volume of vascular filling during the first 4 days
Time Frame: 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 Outcomes
- Analysis of the primary endpoint related to severe renal dysfunction(Day 4)
- .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 patient severity(Day 4)
- Mortality(Day 28)
- Time to normalization of lactatemia (<2 mmol/l)(Day 4)
- Number of days alive without failure at Day 28(Day 28)
- Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics(Day 4)
- Adverse effects(Day 28)
- Fluid balance in L(Day 4)
- Length of stay in ICU (ready for discharge)(Day 28)
- Length of stay in hospital(Day 28)