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

Not Applicable

Not yet recruiting

• Conditions: Sepsis; Septic Shock
• Interventions: Drug: Fluid therapy; Drug: Noradrenaline infusion

• Registration Number: NCT06853574
• Lead Sponsor: General and Teaching Hospital Celje

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-31
• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluids	Fluid therapy	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.
Fluids	Noradrenaline infusion	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.
No fluids	Noradrenaline infusion	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.

Primary Outcome Measures

Name	Time	Method
Changes in myocardial work	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.
Changes in ventriculo-arterial coupling	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.

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure optimal target	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.

Trial Locations

Locations (1)

General Hospital Celje; 🇸🇮 Celje, Slovenia