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

NCT ID: NCT03461900

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 535 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-04
• Study Completion Date: 2024-01-08

Brief Summary

Many observational studies have highlighted an independent association between fluid overload and clinical outcomes during septic shock. To optimize fluid balance, clinician has several options to consider carefully fluid administration and avoid fluid overload. More than a general restrictive approach, a pragmatic, individual tailored approach should be considered to optimize patients' hemodynamics during acute circulatory failure. Many advances in hemodynamic monitoring were described. Mini-fluid challenge appears to be a sensible method to use for bedside assessment to optimize fluid infusion. The next step for hemodynamic management in the ICU should be to test a hemodynamic goal-directed approach to better control fluid management and eventually improve patient's outcome. The main objective of the GOAL study is to evaluate a pragmatic optimization fluid management protocol tailored to each patient's hemodynamic status based on mini-fluid challenges. This intervention will be compared to usual management based on the latest guidelines. This intervention aims to decrease organ dysfunction during septic shock. This is the first large clinical trial designed to test this hypothesis.

Detailed Description

GOAL study is a stepped wedge cluster-randomized trial. Centers will switch randomly from the control to the intervention at regular intervals:

• Control periods: Patients receive a usual optimization fluid management according to surviving sepsis campaign guidelines.
• Interventional periods: Patients receive a pragmatic, protocolized and individual optimization fluid management according to validated components of a hemodynamic challenges called Mini-Fluid Challenge (MFC).

Except fluid therapy in interventional group, management of sepsis will be at the discretion of the attending physician. The use of international guidelines for all therapeutic interventions is recommended in all patients whenever their group.

All patients will be followed from enrolment to death or hospital discharge. If alive but not in the hospital after 28 days since septic shock, clinical outcomes will be evaluated by a visit with an intensivist or, if a physical examination is not possible, by a telephone interview performed by an intensivist. To ensure the same data collection in all centers, visits were planned: D0 (inclusion), D1 to D10 (in ICUs), D28 and D180.

Classical blinded methods cannot be used in case of evaluation of an optimization protocol. Investigators are unblinded to which arm patient is randomized. To ensure the same evaluation for all patients and in all centers, all events recorded will be evaluated by an independent clinical event committee.

All primary endpoints will be analyzed according to a hierarchized analysis to ensure comparison of multiple issues without considering type I error inflation. Secondary outcomes will be analyzed as exploratory analysis.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Minifluid challenge

100 ml of 4% Albumin will be deliver to assess fluid responsiveness

Group Type: EXPERIMENTAL

Minifluid challenge

Intervention Type: OTHER

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.

Control

Patient will be treated as defined by most recent surviving sepsis campaign guidelines

Group Type: EXPERIMENTAL

Usual practice

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Usual practice

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patient (Age > 18 years)
• Admitted in ICU for less than 3 days.
• Abdominal (excepted urinary tract infection) or pulmonary related septic shock, defined by SEPSIS III criteria diagnosed within less than 12 hours.
• Written consent or oral by the patient (and/or consent signed by the next of skin)
• Patient has social security affiliation or who beneficiary of such social security

Exclusion Criteria

• Patient with life expectancy inferior to 24 hours at the time of inclusion.
• Cardiac arrest
• Allergy to albumin
• Pregnancy
• Traumatic brain injury
• Limitation of invasive therapeutics, palliative care
• Patient under guardianship or curatorship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Angers university hospital

Angers, , France

Besançon university hospital

Besançon, , France

Brest university hospital

Brest, , France

Brest university hospital

Brest, , France

Chartres Hospital

Chartres, , France

Clermont Ferrand university hospital

Clermont-Ferrand, , France

Le Mans hospital

Le Mans, , France

Marseille university horpital

Marseille, , France

Morlaix hospital

Morlaix, , France

Nantes university hospital

Nantes, , France

Nîmes university hospital

Nîmes, , France

George Pompidou university hospital (APHP)

Paris, , France

Kremlin Bicêtre university hospital (APHP)

Paris, , France

Poitiers university hospital

Poitiers, , France

Rouen university hospital

Rouen, , France

Toulon hospital

Toulon, , France

Tours university hospital

Tours, , France

Hôpital privé de l'ouest parisen

Trappes, , France

Countries

France

References

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Other Identifiers

29BRC18.0054

Identifier Type: -

Identifier Source: org_study_id