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

NCT06043505 | Recruiting

• 1 other identifier: 2023-A00111-44
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock, Septic; Hemodynamic Instability

Keywords

Monitoring; Transthoracic Echocardiography; Blood Volume; Fluid management

Outcome Measures

Primary Outcomes (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)

  Day 4

Secondary Outcomes (11)

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

  Day 4

• Analysis of the primary endpoint related to severe renal dysfunction

  Day 4

• Analysis of the primary endpoint in relation with patient severity

  Day 4

• Mortality

  Day 28

• Number of days alive without failure at Day 28

  Day 28

Study Arms (2)

Interventional Strategy: STOPFLUID Algorithm

EXPERIMENTAL

Fluid 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.

Other: Echographic hemodynamic algorithm guiding fluid resuscitation

Standard Strategy

NO INTERVENTION

Fluid 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)

Interventions

Echographic hemodynamic algorithm guiding fluid resuscitation OTHER

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 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 3. 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

Interventional Strategy: STOPFLUID Algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

RECRUITING

Related Publications (7)

• 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.

  PMID: 22738085 BACKGROUND

• 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.

  PMID: 27037982 BACKGROUND

• 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.

  PMID: 16984837 BACKGROUND

• 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.

  PMID: 32353418 BACKGROUND

• 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.

  PMID: 21792056 BACKGROUND

• 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.

  PMID: 28640019 BACKGROUND

• 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.

  PMID: 19809049 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Claire Roger

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Roger, MD

CONTACT

04.66.68.30.50; Claire.roger@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: September 21, 2023
• Study Start: February 8, 2024
• Primary Completion: September 26, 2024
• Study Completion: October 26, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)