Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management

Not Applicable

Recruiting

• Conditions: Hemodynamic Instability; Shock, 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

Study Timeline

• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-21
• Study Start: 2024-02-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-09-26
• Study Completion: 2024-10-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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.

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