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NCT Number: NCT06853574

Ventriculo-arterial Coupling and Myocardial Work in Sepsis and Septic Shock

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid therapy

Drug

Infusion of 8 ml/Kg/30' or 16 ml/kg/60' of fluids.

Noradrenaline infusion

Drug

dosage will be titrated in order to obtain mean arterial pressure target

Other names: Vasopressin infusion

Primary outcomes

  1. Changes in ventriculo-arterial coupling

    Time frame: From enrollment to 24 hours after treatment start

    ventricular coupling will be analyzed on admission and its changes after treatment will be observed. To analyze ventriculo-arterial coupling, invasive blood pressure through either a radial or femoral arterial line will be collected and then data will be plotted into iElastance app available on smartphones to get the also knows as single beat determination ventriculo-arterial coupling.

  2. Changes in myocardial work

    Time frame: From enrollment to 24 hours after treatment start

    Myocardial work will be analyzed on admission and its changes after treatment will be observed. To realize this, a transthoracic cardiac ultrasound will be performed and the images will be transferred to EchoPAC from General Electrics (GE) to get the pressure-volume strain analysis also known as myocardial work.

Secondary outcomes

  1. Mean arterial pressure optimal target

    Time frame: From enrollment to 24 hours after treatment start

    The study aims to identify the optimal mean arterial pressure (MAP) target in sepsis and septic shock with the combined evaluation of myocardial work and ventriculo-arterial coupling. To realize this, invasive blood pressure through either a radial or femoral arterial line will be collected and then data will be plotted into iElastance app available on smartphones to get the also knows as single beat determination ventriculo-arterial coupling.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Dr. D'Angelo, Emergency medicine resident

CONTACT

[email protected]

+393313550085

Matej Prof. Dr. Podbregar, Intensive care medicine

CONTACT

[email protected]

+38640215960

Sponsors and collaborators

Lead sponsor

General and Teaching Hospital Celje

Other

Registry information

Official study title

Changes in Ventriculo-arterial Coupling and Myocardial Work During Treatment of Sepsis and Septic Shock: a Prospective Interventional Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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