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"Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools" (MINI3)

23. října 2021 aktualizováno: Humanitas Clinical and Research Center

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

Přehled studie

Postavení

Nábor

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Očekávaný)

45

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Novara, Itálie, 28100
        • Zápis na pozvánku
        • Antonio Messina
    • Milano
      • Rozzano, Milano, Itálie, 20089
        • Nábor
        • Humanitas Research Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

N/A

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Agreement of allocation
Časové okno: 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)
immediately after the procedure

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Least significant change of the stroke volume - PICCO
Časové okno: 5 minutes before FC administration
off-line analysis of the recorded stroke volume change before the test
5 minutes before FC administration
Least significant change of the stroke volume - MOSTCARE
Časové okno: 5 minutes before FC administration
off-line analysis of the recorded stroke volume change before the test
5 minutes before FC administration
Least significant change of the stroke volume - Echocardiography
Časové okno: 5 minutes before FC administration
off-line analysis of the recorded stroke volume change before the test
5 minutes before FC administration
ROC curve - PICCO
Časové okno: 1 minute after mini fluid challenge infusion
ROC curve analysis of stroke volume changes after mini fluid challenge infusion
1 minute after mini fluid challenge infusion
ROC curve - MOSTCARE
Časové okno: 1 minute after mini fluid challenge infusion
ROC curve analysis of stroke volume changes after mini fluid challenge infusion
1 minute after mini fluid challenge infusion
ROC curve - Echocardiograhy
Časové okno: 1 minute after mini fluid challenge infusion
ROC curve analysis of stroke volume changes after mini fluid challenge infusion
1 minute after mini fluid challenge infusion
Agreement stroke volume estimation - MOSTCARE versus PICCO
Časové okno: 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.
immediately after the procedure
Agreement stroke volume estimation - Echocardiography versus PICCO
Časové okno: 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.
immediately after the procedure

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

22. října 2021

Primární dokončení (Očekávaný)

1. září 2022

Dokončení studie (Očekávaný)

1. září 2022

Termíny zápisu do studia

První předloženo

11. června 2021

První předloženo, které splnilo kritéria kontroly kvality

20. června 2021

První zveřejněno (Aktuální)

22. června 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. listopadu 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. října 2021

Naposledy ověřeno

1. října 2021

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu IPD

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Informace o lécích a zařízeních, studijní dokumenty

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Studuje produkt zařízení regulovaný americkým úřadem FDA

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