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

Hemodynamic Instability Clinical Trial

— STOPFLUID  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043505
• Other study ID #: 2023-A00111-44
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: October 26, 2024

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Claire Roger, MD
• Phone: 04.66.68.30.50
• Email: Claire.roger[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: October 26, 2024
• Est. primary completion date: September 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamic Instability
• Shock
• Shock, Septic

Intervention

Other:
• Echographic hemodynamic algorithm guiding fluid resuscitation
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

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: N Engl J Med. 2012 Aug 2;367(5):481. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	.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	Day 4
Secondary	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.	Day 4
Secondary	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	Day 4
Secondary	Mortality	Patient deceased: yes or no	Day 28
Secondary	Number of days alive without failure at Day 28	Number of days without failure	Day 28
Secondary	Time to normalization of lactatemia (<2 mmol/l)	Represents time from randomization to first lactatemia <2 mmol/l in hours	Day 4
Secondary	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	Day 4
Secondary	Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics	Number of therapeutic adjustments	Day 4
Secondary	Length of stay in ICU (ready for discharge)	Length of stay in ICU from randomization to discharge in days	Day 28
Secondary	Length of stay in hospital	Number	Day 28
Secondary	Adverse effects	Number and type of adverse events	Day 28