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

NCT04934943 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-06-29

No results posted yet for this 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

Conditions

  • Sepsis
  • Shock, Septic
  • Critically Ill

Interventions

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

Sponsors & Collaborators

  • Humanitas Clinical and Research Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-08-01
Completion
2025-08-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04934943 on ClinicalTrials.gov