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Clinical Trials in Italy / NCT04934943
Starting soon Observational

"Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools"

NCT04934943 · tracked via the Priya Life Science Italy tracker
Sponsor
Humanitas Clinical and Research Center
Phase
Observational
Started
2025-08-01
Last updated
2025-06-29

Condition(s) studied

SepsisShock, SepticCritically Ill

Investigational drug(s) / intervention(s)

mini_FC

mini_FC: 100 ml of Crystalloids infused over 1 minute - data recording and new baseline - FC 4 ml/kg in 10 minutes - data recording

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria 1\) Acute circulatory failure defined as: * SAP ≤ 90 mmHg (or a decrease \> 50 mm Hg in hypertensive patients) * or a mean arterial pressure (MAP) ≤ 70 mmHg * or the use of vasopressors to maintain SAP \>90 mmHg, * associated with skin mottling; tachycardia ≥100 beats/min; urinary flow ≤0.5 mL/kg for at least 2 hours; blood lactate level ≥4 mmol/L. Exclusion criteria: * known severe myocardial or valvular dysfunction * cardiac arrhythmias * severe acute respiratory distress syndrome * on-going haemodialysis or continuous hemofiltration * moribund patients * persistent low quality of the arterial signal affecting hemodynamic monitoring measurements * poor echographic windows.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Humanitas Research Hospital Rozzano MILANO
Antonio Messina Novara Novara

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04934943 on ClinicalTrials.gov ↗ ← All trials in Italy