Skip to main content
OpenTrials
Completed

NCT Number: NCT06043505

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shock, Septic Hemodynamic Instability Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echographic hemodynamic algorithm guiding fluid resuscitation

Other

Ultrasound Hemodynamic Algorithm (UHA):

  • st step: 1/ Assessment of left ventricular filling pressures by Mitral Doppler echocardiography (2) 2/ Pulmonary ultrasound on 4 anterior dials (3)

E/Ea >14 and/or E/A >2

  • YES => No filling test => Bilateral anterior B lines on lung ultrasound => YES => Consider administration of diuretics
  • NO => Step 2
  • nd step: Assessment of filling response by dynamic maneuvers VTI (Velocity Time Integral) increase >15% after passive leg raising (4) or Mini-fluid challenge (5,6) Or decision of a 250ml filling test
  • YES => consider 250ml bolus filling
  • NO => stop vascular filling
  • rd step if dynamic maneuvers in favor of a response to filling: 1/ Assessment of response to 250ml filling 2/ If no response to vascular filling: Pulmonary ultrasound on 4 anterior dials (3) Change from a pulmonary profile A to a pulmonary profile B
  • YES => depletion
  • NO => stop vascular filling

Primary outcomes

  1. 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

  1. .Analysis of the primary endpoint related to ARDS ([acute respiratory distress syndrome, according to Berlin criteria)

    Time frame: Day 4

    Analysis of the primary endpoint in relation with presence or absence of ARDS at inclusion

  2. Analysis of the primary endpoint related to severe renal dysfunction

    Time frame: 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.

  3. Analysis of the primary endpoint in relation with patient severity

    Time frame: Day 4

    Analysis of the primary endpoint in relation withpatient severity according to SAPS 2 (Simplified Acute Physiology Score) score: <15, 15-30, >30

  4. Mortality

    Time frame: Day 28

    Patient deceased: yes or no

  5. Number of days alive without failure at Day 28

    Time frame: Day 28

    Number of days without failure

  6. Time to normalization of lactatemia (<2 mmol/l)

    Time frame: Day 4

    Represents time from randomization to first lactatemia <2 mmol/l in hours

  7. Fluid balance in L

    Time frame: Day 4

    The fluid balance will be deduced from the daily weight changes in kilograms, the density of water being equal to 1

  8. Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics

    Time frame: Day 4

    Number of therapeutic adjustments

  9. Length of stay in ICU (ready for discharge)

    Time frame: Day 28

    Length of stay in ICU from randomization to discharge in days

  10. Length of stay in hospital

    Time frame: Day 28

    Number

  11. Adverse effects

    Time frame: Day 28

    Number and type of adverse events

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: STOPFLUID

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.