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Non-invasive Hemodynamic Optimization of Sepsis in Internal Medicine: a Randomized Study Comparing Therapy Guided by Non-invasive Hemodynamic Indices Versus Standard of Care.

RecruitingNAAges 18 Years - anyAllRegione del Veneto - AULSS n. 7 Pedemontana
NCT07863323 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background and Rationale Sepsis affects 20 to 30 million people globally each year, with an estimated 48.9 million cases in 2017. Despite medical advances, it still carries a high risk of death. Since sepsis progresses rapidly, early treatment is essential. This includes not only starting antibiotics quickly but also managing fluid levels effectively. Research suggests that in sepsis, fluid problems are often due to poor distribution in the body rather than an actual lack of fluids. Currently, fluid and blood pressure management is often based only on monitoring arterial pressure, which may not provide a full picture of what's happening in the patient's circulatory system. More advanced indicators like Stroke Volume, Cardiac Output, and Peripheral Vascular Resistance can offer better guidance to optimize treatment and improve outcomes. New non-invasive devices such as NICaS (Non-Invasi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Provision of specific informed consent; * Confirmed or suspected diagnosis of sepsis, defined according to the latest SSC guidelines as: "the presence of a clear or suspected infection with life-threatening organ dysfunction caused by a dysregulated host response to infection indicated by a SOFA (Sequential Organ Failure Assessment) score ≥ 2"; * Patients of both sexes, aged 18 years or older; * Patients evaluated in the Emergency Department for suspected infection requiring hospital admission, at the General Medicine ward of Ospedale Alto Vicentino in Santorso (VI, Italy) or the Emergency Medicine ward of the Policlinico Universitario of Pisa (Italy). Exclusion Criteria: * Stay in the Emergency Department of more than six hours, considered as the time between ED admission and ward admission; * Administration of more than 1000 cc of crystalloid therapy in the three hours prior to patient arrival in the ward; * Any admission from a facility or ward other than the Emergency Department; * Sepsis related to an ongoing hospital stay or any sepsis not fitting the definition of community-acquired infection; * Previous hospital admission within four weeks prior to ED access; * Sepsis related to trauma; * Presence of severe oncological disease with life expectancy less than 3 months at enrollment; * Active major bleeding; * Dialysis therapy; * Suspected or confirmed pregnancy; * Age under 18 years; * Patients who do not provide informed consent to the study.
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What it tests

  • non-invasive hemodynamic assessment
  • Treatment per SSC Guidelines
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Where

2 sites
Policlinico Universitario di Pisa - UOC Medicina d'Urgenza
Pisa, Italy
AULSS 7 Pedemontana - UOC Medicina Generale PO Alto Vicentino - Santorso (VI)
Santorso, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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