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Shock, SepticSTOPFLUIDNCT06043505

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

A study testing Echographic hemodynamic algorithm guiding fluid resuscitation in people with Shock, Septic and Hemodynamic Instability, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shock, Septic, Hemodynamic Instability
What is being tested?
Echographic hemodynamic algorithm guiding fluid resuscitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteFrance
Study dates
8 Feb 2024to 15 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Intracavitary thrombus.
  • Dilated cardiomyopathy with LVEF (Left Ventricular Ejection Fraction<40%.
  • Parturient or nursing patient.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Nimes

    Nîmes, 30029

Other trials in France

About this study

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

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.

Being tested
Echographic hemodynamic algorithm guiding fluid resuscitation
Keywords
Monitoring, Transthoracic Echocardiography, Blood Volume, Fluid management
Medical subject headings
Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Echographic hemodynamic algorithm guiding fluid resuscitationOther

    Ultrasound Hemodynamic Algorithm (UHA):

    1. 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
    1. 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
    1. 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
Study groups in NCT06043505
Study groupRoleWhat they receive
Interventional Strategy: STOPFLUID AlgorithmExperimentalFluid management is optimised using the specific echographic hemodynamic algorithm ('STOPFLUID') of this study described during the first 4 days of septic shock. Fluid bolus will not be administered in case of increased left ventricle filling pressures; fluid challenge will be performed based on dynamic indices and fluid depletion will be considered on the basis of Lung UltraSound (LUS) assessment.
Receives: Other: Echographic hemodynamic algorithm guiding fluid resuscitation
Standard StrategyNo interventionFluid management will be handled according to standard care, without using transthoracic echocardiography (TTE) during the first 4 days of septic shock management. Haemodynamic monitoring including pulmonary artery catheter, transpulmonary thermodilution, or any other device will be left at the physician's discretion. TTE will be allowed in the standard group only for excluding cardiac tamponade in case of clinical suspicion (one or more of the following signs: jugular distension, pulsus paradoxus)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volume of vascular filling during the first 4 days

    This takes into account the cumulative volume of vascular filling administered to improve cardiac output during the 4 first days, measured in Liter (L)

    Measured: Day 4

Secondary outcomes (11)

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

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

    Measured: Day 4

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

    Analysis of the primary endpoint in relation with severe renal dysfunction defined as a KDIGO (Kidney Disease Improving Global Outcomes) score ≥3 vs <3.

    Measured: Day 4

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

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

    Measured: Day 4

  4. Mortality

    Patient deceased: yes or no

    Measured: Day 28

  5. Number of days alive without failure at Day 28

    Number of days without failure

    Measured: Day 28

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

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

    Measured: Day 4

  7. Fluid balance in L

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

    Measured: Day 4

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

    Number of therapeutic adjustments

    Measured: Day 4

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

    Length of stay in ICU from randomization to discharge in days

    Measured: Day 28

  10. Length of stay in hospital

    Number

    Measured: Day 28

  11. Adverse effects

    Number and type of adverse events

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start8 Feb 2024
  3. Primary completion15 Apr 2026
  4. Study completion15 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06043505
Sponsor's protocol ID
2023-A00111-44
Acronym
STOPFLUID
Status last verified
Jun 2026
First submitted
30 Jun 2023
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27.

    PubMed 22738085

  • Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.

    PubMed 27037982

  • Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.

    PubMed 16984837

  • Douglas IS, Alapat PM, Corl KA, Exline MC, Forni LG, Holder AL, Kaufman DA, Khan A, Levy MM, Martin GS, Sahatjian JA, Seeley E, Self WH, Weingarten JA, Williams M, Hansell DM. Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial. Chest. 2020 Oct;158(4):1431-1445. doi: 10.1016/j.chest.2020.04.025. Epub 2020 Apr 27.

    PubMed 32353418

  • Muller L, Toumi M, Bousquet PJ, Riu-Poulenc B, Louart G, Candela D, Zoric L, Suehs C, de La Coussaye JE, Molinari N, Lefrant JY; AzuRea Group. An increase in aortic blood flow after an infusion of 100 ml colloid over 1 minute can predict fluid responsiveness: the mini-fluid challenge study. Anesthesiology. 2011 Sep;115(3):541-7. doi: 10.1097/ALN.0b013e318229a500.

    PubMed 21792056

  • Biais M, de Courson H, Lanchon R, Pereira B, Bardonneau G, Griton M, Sesay M, Nouette-Gaulain K. Mini-fluid Challenge of 100 ml of Crystalloid Predicts Fluid Responsiveness in the Operating Room. Anesthesiology. 2017 Sep;127(3):450-456. doi: 10.1097/ALN.0000000000001753.

    PubMed 28640019

  • Lichtenstein DA, Meziere GA, Lagoueyte JF, Biderman P, Goldstein I, Gepner A. A-lines and B-lines: lung ultrasound as a bedside tool for predicting pulmonary artery occlusion pressure in the critically ill. Chest. 2009 Oct;136(4):1014-1020. doi: 10.1378/chest.09-0001.

    PubMed 19809049

Questions about this trial

What is this clinical trial studying?

A study testing Echographic hemodynamic algorithm guiding fluid resuscitation in people with Shock, Septic and Hemodynamic Instability, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume of vascular filling during the first 4 days (time frame: Day 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06043505, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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