Not Yet RecruitingNot Applicable

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

Italy45 participantsStarted 2025-08-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Agreement of allocation

Timeframe: immediately after the procedure

Trial details

NCT IDNCT04934943

SponsorHumanitas Clinical and Research Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-01

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