Ventriculo-arterial Coupling and Myocardial Work in Sepsis and Septic Shock
NCT ID: NCT06853574
Last Updated: 2025-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-02-28
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Fluids
The patients will be included in this arm on admission basing on the absence of peripheral edema, presence of apical A lines at lung ultrasound, inferior vena cava width \< 2 cm and velocity-time integral (VTI) variation \> 10%.
If the fluid therapy will not be effective, patients will also receive vasopressors.
Fluid therapy
Infusion of 8 ml/Kg/30' or 16 ml/kg/60' of fluids.
Noradrenaline infusion
dosage will be titrated in order to obtain mean arterial pressure target
No fluids
The patients will be included in this arm on admission basing on the presence of peripheral edema, presence of apical B lines at lung ultrasound, inferior vena cava width \> 2 cm and velocity-time integral (VTI) variation \< 10%.
In this arm the patients will receive vasopressors with an initial mean arterial pressure target of 65 mmHg; then the investigators will target to 80-85 mmHg to observe tha changes in ventriculo-arterial coupling.
Noradrenaline infusion
dosage will be titrated in order to obtain mean arterial pressure target
Interventions
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Fluid therapy
Infusion of 8 ml/Kg/30' or 16 ml/kg/60' of fluids.
Noradrenaline infusion
dosage will be titrated in order to obtain mean arterial pressure target
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* sepsis
* septic shock
Exclusion Criteria
* less than 18 years old
* pregnancy
* more than moderate aortic stenosis ( aortic valve area (AVA) \< 1.4 cm2, aortic valve area indexed (AVAi) \< 0.85, doppler velocity index (DVI) \< 0.5)
* more than mild mitral regurgitation (vena contracta (VC) width \<= 3 mm, mitral regurgitation (MR) effective regurgitant orifice area (EROA) \< 20, MR regurgitant volume (RegV) \< 30 ml)
* cardiac arrythmias (e.g. atrial fibrillation/flutter, frequent ventricular and supraventricular or nodal activity)
* renal replacement therapy
* other than continous modes of mechanical ventilation
18 Years
ALL
No
Sponsors
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General and Teaching Hospital Celje
OTHER
Responsible Party
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Matej Podbregar
Prof. Dr. Matej Podbregar
Locations
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General Hospital Celje
Celje, , Slovenia
Countries
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Central Contacts
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Facility Contacts
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References
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Sunagawa K, Sagawa K, Maughan WL. Ventricular interaction with the loading system. Ann Biomed Eng. 1984;12(2):163-89. doi: 10.1007/BF02584229.
Kakihana Y, Nishida O, Taniguchi T, Okajima M, Morimatsu H, Ogura H, Yamada Y, Nagano T, Morishima E, Matsuda N; J-Land 3S Study Group. Efficacy and safety of landiolol, an ultra-short-acting beta1-selective antagonist, for treatment of sepsis-related tachyarrhythmia (J-Land 3S): a multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2020 Sep;8(9):863-872. doi: 10.1016/S2213-2600(20)30037-0. Epub 2020 Mar 31.
Morelli A, Ertmer C, Westphal M, Rehberg S, Kampmeier T, Ligges S, Orecchioni A, D'Egidio A, D'Ippoliti F, Raffone C, Venditti M, Guarracino F, Girardis M, Tritapepe L, Pietropaoli P, Mebazaa A, Singer M. Effect of heart rate control with esmolol on hemodynamic and clinical outcomes in patients with septic shock: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1683-91. doi: 10.1001/jama.2013.278477.
Nasrollahi-Shirazi S, Sucic S, Yang Q, Freissmuth M, Nanoff C. Comparison of the beta-Adrenergic Receptor Antagonists Landiolol and Esmolol: Receptor Selectivity, Partial Agonism, and Pharmacochaperoning Actions. J Pharmacol Exp Ther. 2016 Oct;359(1):73-81. doi: 10.1124/jpet.116.232884. Epub 2016 Jul 22.
Zhou X, Pan J, Wang Y, Wang H, Xu Z, Zhuo W. Left ventricular-arterial coupling as a predictor of stroke volume response to norepinephrine in septic shock - a prospective cohort study. BMC Anesthesiol. 2021 Feb 17;21(1):56. doi: 10.1186/s12871-021-01276-y.
Chen CH, Fetics B, Nevo E, Rochitte CE, Chiou KR, Ding PA, Kawaguchi M, Kass DA. Noninvasive single-beat determination of left ventricular end-systolic elastance in humans. J Am Coll Cardiol. 2001 Dec;38(7):2028-34. doi: 10.1016/s0735-1097(01)01651-5.
Zhou X, Zhang Y, Pan J, Wang Y, Wang H, Xu Z, Chen B, Hu C. Optimizing left ventricular-arterial coupling during the initial resuscitation in septic shock - a pilot prospective randomized study. BMC Anesthesiol. 2022 Jan 21;22(1):31. doi: 10.1186/s12871-021-01553-w.
Antonini-Canterin F, Poli S, Vriz O, Pavan D, Bello VD, Nicolosi GL. The Ventricular-Arterial Coupling: From Basic Pathophysiology to Clinical Application in the Echocardiography Laboratory. J Cardiovasc Echogr. 2013 Oct-Dec;23(4):91-95. doi: 10.4103/2211-4122.127408.
Andrei S, Bahr PA, Berthoud V, Popescu BA, Nguyen M, Bouhemad B, Guinot PG. Diuretics depletion improves cardiac output and ventriculo-arterial coupling in congestive ICU patients during hemodynamic de-escalation. J Clin Monit Comput. 2023 Aug;37(4):1035-1043. doi: 10.1007/s10877-023-01011-7. Epub 2023 Apr 25.
Bischoff AR, Stanford AH, McNamara PJ. Short-term ventriculo-arterial coupling and myocardial work efficiency in preterm infants undergoing percutaneous patent ductus arteriosus closure. Physiol Rep. 2021 Nov;9(22):e15108. doi: 10.14814/phy2.15108.
Demailly Z, Besnier E, Tamion F, Lesur O. Ventriculo-arterial (un)coupling in septic shock: Impact of current and upcoming hemodynamic drugs. Front Cardiovasc Med. 2023 May 30;10:1172703. doi: 10.3389/fcvm.2023.1172703. eCollection 2023.
Rehn M, Chew MS, Olkkola KT, Ingi Sigurethsson M, Yli-Hankala A, Hylander Moller M. Surviving sepsis campaign: International guidelines for management of sepsis and septic shock in adults 2021 - endorsement by the Scandinavian society of anaesthesiology and intensive care medicine. Acta Anaesthesiol Scand. 2022 May;66(5):634-635. doi: 10.1111/aas.14045. Epub 2022 Mar 6.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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70/2025/6-1
Identifier Type: -
Identifier Source: org_study_id
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