Non-invasive hemodynamic guidance for sepsis care on medical wards

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial compares a non-invasive hemodynamic-guided strategy to usual care for adults with suspected or confirmed sepsis admitted to medical wards. It uses the NICaS device to measure parameters like cardiac index and systemic vascular resistance to tailor fluid boluses and vasopressor decisions. After an initial fluid challenge, treatment decisions are driven by the hemodynamic response rather than arterial pressure alone. The study is open-label and assigns participants 1:1 to the two strategies, with serial assessments to refine therapy. Primary endpoints focus on hemodynamic stabilization and clinical outcomes in sepsis and septic shock.

Why it matters

Who can join: the full rules

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.

Where it's running

• Policlinico Universitario di Pisa - UOC Medicina d'Urgenza
  Pisa, Pisa, Italy Recruiting
• AULSS 7 Pedemontana - UOC Medicina Generale PO Alto Vicentino - Santorso (VI)
  Santorso, Vicenza, Italy Recruiting

Study contacts

• Study coordinator: Massimo Marchetti, Dr.
• Email: massimo.marchetti@aulss7.veneto.it
• Phone: +39 0445571608

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Personalized Fluid Resuscitation in the Emergency Department

  This pilot test checks if a quick, non-invasive stroke-volume assessment can help ED doctors tailor IV fluids for septic patients with low blood pressure.

  Recruiting Intermountain Health Care, Inc. · Murray, Utah · NCT07779720

• Discordance between capillary refill time and oxygen use in septic shock

  This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.

  Recruiting Istanbul University - Cerrahpasa · Istanbul · NCT07774962

• Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock

  This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.

  Recruiting Alexandria University · Alexandria, Alexandria Governorate · NCT07716956

• Cortisol Levels and Mortality in Septic Shock ICU Patients

  This study tests whether cortisol levels can predict death or recovery in adults with sepsis or septic shock in the ICU.

  Recruiting Ankara Etlik City Hospital · Ankara · NCT07582926

• oXiris hemofilter use for adults with septic shock and kidney failure

  This study tests whether using the oXiris hemofilter during continuous dialysis helps adults with septic shock and acute kidney injury survive and stabilize faster.

  Recruiting Seoul National University Bundang Hospital · Seongnam-si, Gyeonggi-do · NCT07539883

• Adjunctive Fludrocortisone in Septic Shock

  This study tests adding fludrocortisone to usual care for adults with septic shock to see if it helps patients survive and recover better.

  Recruiting Phase 2 Chinese University of Hong Kong · Hong Kong and 4 other locations · NCT07451886

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.