Ventriculo-arterial Coupling and Myocardial Work in Sepsis and Septic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluid therapy, Noradrenaline infusion.
- Who it may be relevant to
- Registry conditions: Sepsis, Septic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Changes in Ventriculo-arterial Coupling and Myocardial Work During Treatment of Sepsis and Septic Shock: a Prospective Interventional Study
Overview
Sepsis is a term which describes an excessive response of the body to an infection and, if not promptly treated, can turn into septic shock a condition in which the organs don't receive enough oxygen to satisfy their needs. The aim of the study is to assess how the treatment of sepsis and septic shock will modify myocardial work and ventriculo-arterial coupling, that can be considered as indicators of ventricular and arterial performance efficacy respectively. Each patient will be treated according to updated guidelines for sepsis and septic shock management, they will voluntarily be enrolled and they can decide to withdraw in each moment without any consequence on their treatment. The investigators, after receiving the consent, will collect patients' data, take blood samples and perform ultrasound measurements and then will start the treatment which can be based on fluids infusion, vasopressors or both. The investigators think that a modern cardiovascular assessment approach can be used to individually set the optimal blood pressure target in sepsis and septic shock with the combined evaluation of myocardial work and ventriculo-arterial coupling.
Interventions
- Drug Fluid therapy
Infusion of 8 ml/Kg/30' or 16 ml/kg/60' of fluids. - Drug Noradrenaline infusion
dosage will be titrated in order to obtain mean arterial pressure target
Primary outcome measures
- Changes in ventriculo-arterial coupling [Time frame: From enrollment to 24 hours after treatment start]
- Changes in myocardial work [Time frame: From enrollment to 24 hours after treatment start]
Secondary outcome measures (1)
- Mean arterial pressure optimal target [Time frame: From enrollment to 24 hours after treatment start]
Eligibility criteria
Inclusion criteria
- 18 or more years old
- sepsis
- septic shock
Exclusion criteria
- lack of consent
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Slovenia · 1 center
- General Hospital Celje — Celje
Publications
- Sunagawa K, Sagawa K, Maughan WL. Ventricular interaction with the loading system. Ann Biomed Eng. 1984;12(2):163-89. doi: 10.1007/BF02584229. PMID 6507965
- 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/S2213-26 PMID 32243865
- 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.201 PMID 24108526
- 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. PMID 27451411
- 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. PMID 33596822
- 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. PMID 11738311
- 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. PMID 35062874
- 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. PMID 28465893
Identifiers
NCT: NCT06853574 · 70/2025/6-1