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

General and Teaching Hospital Celje

Status: Not yet enrolling

Conditions: Septic Shock; Sepsis

Treatments: Drug: Fluid therapy; Drug: Noradrenaline infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06853574

70/2025/6-1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Fluids

Active Comparator group

Description:

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.

Treatment:

Drug: Noradrenaline infusion

Drug: Fluid therapy

No fluids

Active Comparator group

Description:

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.

Treatment:

Drug: Noradrenaline infusion