Clinical trial NCT06853574: Ventriculo-arterial Coupling and Myocardial Work in Sepsis and Septic Shock
Official title: Changes in Ventriculo-arterial Coupling and Myocardial Work During Treatment of Sepsis and Septic Shock: a Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sepsis
Septic Shock
Keywords: sepsis
septic shock
myocardial work
ventriculo-arterial coupling
ICU
intensive care
Lead sponsor: General and Teaching Hospital Celje
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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

Primary outcomes:
measure: Changes in ventriculo-arterial coupling
timeFrame: From enrollment to 24 hours after treatment start
measure: Changes in myocardial work
timeFrame: From enrollment to 24 hours after treatment start
Secondary outcomes:
measure: Mean arterial pressure optimal target
timeFrame: From enrollment to 24 hours after treatment start
Other outcomes:
Locations:
city: Celje
country: Slovenia
facility: General Hospital Celje
Study officials:
References:
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