Guided Fluid-balance Optimization With Mini-fluid chALlenge During Septic Shock

NACompletedINTERVENTIONAL
Enrollment

535

Participants

Timeline

Start Date

June 4, 2019

Primary Completion Date

August 9, 2023

Study Completion Date

January 8, 2024

Conditions
Septic Shock
Interventions
OTHER

Minifluid challenge

Pragmatic optimization fluid management protocol based on Mini-Fluid Challenge (MFC) in treating an acute circulatory failure. MFC consist of an infusion of 100 ml of colloid solution (4% human serum albumin) during 1 minute via a separate venous line. Before and after each MFC and depending on the hemodynamic device used, the attending physician will perform a first set of hemodynamic measurements, including cardiac index (CI) or cardiac output (CO); stroke volume (SV), indexed stroke volume (iSV) or velocity time index (VTI). If the variation in measurement is superior to 10%, the attending physician will infuse 400 ml of buffered crystalloid solution or saline solution. After an infusion of 500 ml, fluid responsiveness will be evaluated with CI or CO measurement. For non-responders, fluid challenge must be stopped and other therapeutics should be considered. For responder, another MFC should be consider if hemodynamic status is not stabilized.

OTHER

Usual practice

Patients included in control group will be managed according to the last surviving sepsis recommendations edited in 2017.

Trial Locations (18)

28000

Chartres Hospital, Chartres

29200

Brest university hospital, Brest

30029

Nîmes university hospital, Nîmes

78190

Hôpital privé de l'ouest parisen, Trappes

Unknown

Angers university hospital, Angers

Besançon university hospital, Besançon

Brest university hospital, Brest

Clermont Ferrand university hospital, Clermont-Ferrand

Le Mans hospital, Le Mans

Marseille university horpital, Marseille

Morlaix hospital, Morlaix

Nantes university hospital, Nantes

George Pompidou university hospital (APHP), Paris

Kremlin Bicêtre university hospital (APHP), Paris

Poitiers university hospital, Poitiers

Rouen university hospital, Rouen

Toulon hospital, Toulon

Tours university hospital, Tours

All Listed Sponsors
lead

University Hospital, Brest

OTHER

NCT03461900 - Guided Fluid-balance Optimization With Mini-fluid chALlenge During Septic Shock | Biotech Hunter | Biotech Hunter