Clinical trial NCT06043505: Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shock, Septic
Hemodynamic Instability
Keywords: Monitoring
Transthoracic Echocardiography
Blood Volume
Fluid management
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Volume of vascular filling during the first 4 days
timeFrame: Day 4
Secondary outcomes:
measure: .Analysis of the primary endpoint related to ARDS ([acute respiratory distress syndrome, according to Berlin criteria)
timeFrame: Day 4
measure: Analysis of the primary endpoint related to severe renal dysfunction
timeFrame: Day 4
measure: Analysis of the primary endpoint in relation with patient severity
timeFrame: Day 4
measure: Mortality
timeFrame: Day 28
measure: Number of days alive without failure at Day 28
timeFrame: Day 28
measure: Time to normalization of lactatemia (<2 mmol/l)
timeFrame: Day 4
measure: Fluid balance in L
timeFrame: Day 4
measure: Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics
timeFrame: Day 4
measure: Length of stay in ICU (ready for discharge)
timeFrame: Day 28
measure: Length of stay in hospital
timeFrame: Day 28
measure: Adverse effects
timeFrame: Day 28
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Claire Roger
role: PRINCIPAL_INVESTIGATOR
References:
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