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NCT Number: NCT04934943

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanitas Research Hospital, Rozzano, MILANO, Italy

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

mini_FC

Diagnostic Test

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

Primary outcomes

  1. Agreement of allocation

    Time frame: immediately after the procedure

    Number of responders and non-responders identified by the MOSTCARE and the Echocardiography with respect to the PICCO system (considered as gold standard)

Secondary outcomes

  1. Least significant change of the stroke volume - PICCO

    Time frame: 5 minutes before FC administration

    off-line analysis of the recorded stroke volume change before the test

  2. Least significant change of the stroke volume - MOSTCARE

    Time frame: 5 minutes before FC administration

    off-line analysis of the recorded stroke volume change before the test

  3. Least significant change of the stroke volume - Echocardiography

    Time frame: 5 minutes before FC administration

    off-line analysis of the recorded stroke volume change before the test

  4. ROC curve - PICCO

    Time frame: 1 minute after mini fluid challenge infusion

    ROC curve analysis of stroke volume changes after mini fluid challenge infusion

  5. ROC curve - MOSTCARE

    Time frame: 1 minute after mini fluid challenge infusion

    ROC curve analysis of stroke volume changes after mini fluid challenge infusion

  6. ROC curve - Echocardiograhy

    Time frame: 1 minute after mini fluid challenge infusion

    ROC curve analysis of stroke volume changes after mini fluid challenge infusion

  7. Agreement stroke volume estimation - MOSTCARE versus PICCO

    Time frame: immediately after the procedure

    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.

  8. Agreement stroke volume estimation - Echocardiography versus PICCO

    Time frame: immediately after the procedure

    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.

Sponsors and collaborators

Lead sponsor

Humanitas Clinical and Research Center

Other

Registry information

Acronym: MINI3

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2021
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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