Sepsis, Septic Shock
Conditions
Keywords
sepsis, septic shock, myocardial work, ventriculo-arterial coupling, ICU, intensive care
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.
Interventions
DRUGFluid therapy
Infusion of 8 ml/Kg/30' or 16 ml/kg/60' of fluids.
dosage will be titrated in order to obtain mean arterial pressure target
Sponsors
General and Teaching Hospital Celje
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Slovenia
Contacts
Primary ContactMatej Prof. Dr. Podbregar, Intensive care medicine
Backup ContactAndrea Dr. D'Angelo, Emergency medicine resident
Outcome results
None listed