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

NCT04934943 | Not Yet Recruiting

• 1 other identifier: MINI3
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Fluid challenge; Functional hemodynamic test

Outcome Measures

Primary Outcomes (1)

• 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)

  immediately after the procedure

Secondary Outcomes (8)

• Least significant change of the stroke volume - PICCO

  5 minutes before FC administration

• Least significant change of the stroke volume - MOSTCARE

  5 minutes before FC administration

• Least significant change of the stroke volume - Echocardiography

  5 minutes before FC administration

• ROC curve - PICCO

  1 minute after mini fluid challenge infusion

• ROC curve - MOSTCARE

  1 minute after mini fluid challenge infusion

Study Arms (1)

Intervention _mini_FC

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

Interventions

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

Intervention _mini_FC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults critically ill patients with acute circulatory failure, who require volume expansion decided by the clinician in charge.

You may qualify if:

• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (2)

Humanitas Research Hospital

Rozzano, MILANO, 20089, Italy

Location

Antonio Messina

Novara, Novara, 28100, Italy

Location

Related Publications (7)

• Messina A, Lionetti G, Foti L, Bellotti E, Marcomini N, Cammarota G, Bennett V, Saderi L, Sotgiu G, Della Corte F, Protti A, Monge Garcia MI, Romagnoli S, Cecconi M. Mini fluid chAllenge aNd End-expiratory occlusion test to assess flUid responsiVEness in the opeRating room (MANEUVER study): A multicentre cohort study. Eur J Anaesthesiol. 2021 Apr 1;38(4):422-431. doi: 10.1097/EJA.0000000000001406.

  PMID: 33399372 BACKGROUND

• de Courson H, Ferrer L, Cane G, Verchere E, Sesay M, Nouette-Gaulain K, Biais M. Evaluation of least significant changes of pulse contour analysis-derived parameters. Ann Intensive Care. 2019 Oct 11;9(1):116. doi: 10.1186/s13613-019-0590-z.

  PMID: 31602550 BACKGROUND

• Georges D, de Courson H, Lanchon R, Sesay M, Nouette-Gaulain K, Biais M. End-expiratory occlusion maneuver to predict fluid responsiveness in the intensive care unit: an echocardiographic study. Crit Care. 2018 Feb 8;22(1):32. doi: 10.1186/s13054-017-1938-0.

  PMID: 29415773 BACKGROUND

• Messina A, Dell'Anna A, Baggiani M, Torrini F, Maresca GM, Bennett V, Saderi L, Sotgiu G, Antonelli M, Cecconi M. Functional hemodynamic tests: a systematic review and a metanalysis on the reliability of the end-expiratory occlusion test and of the mini-fluid challenge in predicting fluid responsiveness. Crit Care. 2019 Jul 29;23(1):264. doi: 10.1186/s13054-019-2545-z.

  PMID: 31358025 BACKGROUND

• Shi R, Monnet X, Teboul JL. Parameters of fluid responsiveness. Curr Opin Crit Care. 2020 Jun;26(3):319-326. doi: 10.1097/MCC.0000000000000723.

  PMID: 32332283 BACKGROUND

• Vistisen ST, Scheeren TWL. Challenge of the Mini-fluid Challenge: Filling Twice without Creating a Self-fulfilling Prophecy Design. Anesthesiology. 2018 May;128(5):1043-1044. doi: 10.1097/ALN.0000000000002141. No abstract available.

  PMID: 29664782 BACKGROUND

• Biais M, de Courson H, Lanchon R, Pereira B, Bardonneau G, Griton M, Sesay M, Nouette-Gaulain K. Mini-fluid Challenge of 100 ml of Crystalloid Predicts Fluid Responsiveness in the Operating Room. Anesthesiology. 2017 Sep;127(3):450-456. doi: 10.1097/ALN.0000000000001753.

  PMID: 28640019 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 22, 2021
• Study Start: August 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

IT (2)