An observational study in Sepsis, Shock, Septic and Critically Ill, sponsored by Humanitas Clinical and Research Center. Not yet recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by Humanitas Clinical and Research Center · Observational
Among 53 studies in Shock, Septic with a site in Italy — 7 open to participants now, 8 under way, none of them phase 3. Shock, Septic · Italy.
Among the 53 studies in Shock, Septic with a site in Italy, this one is the 13th largest by planned enrollment of the 23 observational ones that give a count, is one of 5 that started in 2025, is one of 23 observational ones, and was the 39th registered.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
Browse Shock, Septic studies →7 of the 53 studies in Shock, Septic with a site in Italy are open now. Recruiting first, the newest first:
Regione del Veneto - AULSS n. 7 Pedemontana · Sites in Italy
Ages 18+
Niguarda Hospital · Sites in Italy
Ages 18+
University of Turin, Italy · Sites in Italy
Ages 18+
Azienda Usl di Bologna · Sites in Italy
Ages 18–80
CytoSorbents, Inc · Sites in Italy, Austria, Germany and 3 more countries
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 136 Shock, Septic studies recruiting now, 102 (75%) set no upper age limit and 19 (14%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
53 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 11 · Phase 3 11 · Phase 4 3
First in 2002; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 45 is below the median of 108 across 406 observational studies indexed under Shock, Septic.
Median enrollment 118 across the 30 interventional studies, 50 across the 23 observational. Of the 37 that completed or were terminated, 3 (8%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 53 have an industry lead sponsor. The 10 most frequent:
Humanitas Clinical and Research Center is the lead sponsor of 33 studies on the registry; 6 are open to participants now.
Humanitas Clinical and Research Center has 3 studies filed under Shock, Septic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 53 studies in Shock, Septic with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The mini fluid challenge (mini_FC) is a functional hemodynamic test which has been used in different clinical contexts to assess fluid responsiveness.
This test is performed by rapidly injecting a small aliquot of fluid (100 ml over 1 minute), which is followed by the infusion of the residual aliquot of fluid.
Since the threshold of the mini_FC identified by the literature is rather small (5% of stroke volume (SV) increase after the 100 ml bolus to discriminate between responder and non-responder), it is crucial that the hemodynamic tool assessing this change could be reliable. Moreover, the SV changes with inspiratory/expiratory movements and the increase after the mini_FC should also consider the physiological fluctuations of the SV.
In the literature this test has been performed by means of tolls with different least significant change of the SV. The least significant change (LSC) represents the smallest difference between successive measurements of SV that can be considered to be a real change and not attributable to chance.
The purpose of this study is to assess the agreement among MOSTCARE system (4.5\& of SV LSC described in the literature) and the echocardiography (about 10% of SV LSC described in the literature) with the PICCO system (about 1% of SV LSC described in the literature - considered the gold standard) in discriminating fluid responsiveness after a mini_FC
Targeted fluid therapy has received increasing attention in the management of patients showing acute circulatory failure in both intensive care unit (ICU) and operating room (OR), aiming at preventing both inadequate tissue blood flow and fluid overload. In fact, unnecessary fluid administration can increase morbidity and mortality and length of hospital stay of critically ill and surgical patients.
Since the only physiological reason to give a fluid challenge (FC) is to increase the stroke volume (SV) and this effect is obtained only in about 50% of ICU and OR patients, a vast literature investigated the possibility of predict this effect before FC administration, but the issue remains extremely challenging. Bedside clinical signs and pressure and static volumetric static variables, do not predict fluid responsiveness. Moreover, several physiological factors affect the reliability of the ventilator-induced dynamic changes in pulse pressure and stroke volume [pulse pressure variation (PPV) and stroke volume (SV) variation (SVV), respectively], and their echographic surrogates, in a significant number of ICU and OR patients.
To overcome these limitations, the functional hemodynamic assessment (i.e. the assessment of the dynamic interactions of hemodynamic variables in response to a defined perturbation), of fluid responsiveness has gained in popularity. A functional hemodynamic test (FHT) consist in a manoeuvre determining a sudden change in cardiac function and/or heart lung interaction, affecting the hemodynamics of fluid responders and non-responders to a different extent.
The FHT called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 and its reliability has been confirmed by three large meta-analyses. However, the PLR is not usually practicable in the OR.
A lot of different FHTs have been proposed, as alternative to the PLR, in ICU and, more recently, OR. These tests could be basically subdivided in two groups. A subgroup of FHTs is based on sudden and brief variations of the mechanical ventilation to induce a change in right ventricle preload and/or after load and, as consequence, of left ventricle. Among these tests, the rapid administration of a small aliquot of the predefined FC (the so-called mini FC) has gained in popularity in the last years.
On of the drawbacks of this test is that the optimal threshold identified in the literature to stratify responders and non-responders (5% of SV variation) is quite small, and potentially affected by the reliability of the hemodynamic tool used. The aim of this paper is to compare the reliability of a hemodynamic invasive tool (the (PiCCO2 TM, Pulsion Medical Systems, Munich, Germany - considered the gold standard) with a mini-invasive tool (MostCareTM system (Vytech Health, Padua, Italy) and a non-invasive (echocardiography) in predicting the response to the mini-FC in critically ill patients.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 45 is below the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Humanitas Clinical and Research Center is the lead sponsor of 33 studies on the registry; 6 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adults critically ill patients with acute circulatory failure, who require volume expansion decided by the clinician in charge.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1) Acute circulatory failure defined as:
Exclusion criteria:
The fluid challenge consists of 4 ml\*Kg of Crystalloids' solution infused over 10 minutes, administered via either a central or a peripheral line. 1. The patient is already connected to the PICCO monitoring for clinical purpose of hemodynamic monitoring (before study enrollment) 2. The MOSTCARE system is connected to the MONITOR of the patient (and not to the patient itself) by means of a cable inserted into the connections system. 3. The echocardiography will be performed by a senior intensivist/cardiologist. The stroke volume is calculated by measuring VTI and diameter at the same point. This is best performed by measuring the diameter of the LVOT in the parasternal long axis (PLAX) view
Diagnostic Test: mini_FC
100 ml of Crystalloids infused over 1 minute - data recording and new baseline - FC 4 ml/kg in 10 minutes - data recording
Agreement of allocation
Number of responders and non-responders identified by the MOSTCARE and the Echocardiography with respect to the PICCO system (considered as gold standard)
Time frame: immediately after the procedure
Least significant change of the stroke volume - PICCO
off-line analysis of the recorded stroke volume change before the test
Time frame: 5 minutes before FC administration
Least significant change of the stroke volume - MOSTCARE
off-line analysis of the recorded stroke volume change before the test
Time frame: 5 minutes before FC administration
Least significant change of the stroke volume - Echocardiography
off-line analysis of the recorded stroke volume change before the test
Time frame: 5 minutes before FC administration
ROC curve - PICCO
ROC curve analysis of stroke volume changes after mini fluid challenge infusion
Time frame: 1 minute after mini fluid challenge infusion
ROC curve - MOSTCARE
ROC curve analysis of stroke volume changes after mini fluid challenge infusion
Time frame: 1 minute after mini fluid challenge infusion
ROC curve - Echocardiograhy
ROC curve analysis of stroke volume changes after mini fluid challenge infusion
Time frame: 1 minute after mini fluid challenge infusion
Agreement stroke volume estimation - MOSTCARE versus PICCO
Agreements between stroke volume data are determined using the Bland-Altman method, with the bias calculated as the mean difference between methods and reflecting the measurement error between the two tests.
Time frame: immediately after the procedure
Agreement stroke volume estimation - Echocardiography versus PICCO
Agreements between stroke volume data are determined using the Bland-Altman method, with the bias calculated as the mean difference between methods and reflecting the measurement error between the two tests.
Time frame: immediately after the procedure
Plan to share: Undecided — The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Start is estimated for Aug 2025; primary completion for Aug 2025, 0 months later.
Of 188 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 0 months is below that.
Counting every sponsor, half of 201 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Humanitas Clinical and Research Center