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

23 octobre 2021 mis à jour par: 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

Aperçu de l'étude

Statut

Recrutement

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

45

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Novara, Italie, 28100
        • Inscription sur invitation
        • Antonio Messina
    • Milano
      • Rozzano, Milano, Italie, 20089
        • Recrutement
        • Humanitas Research Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

N/A

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Agreement of allocation
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Least significant change of the stroke volume - PICCO
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 octobre 2021

Achèvement primaire (Anticipé)

1 septembre 2022

Achèvement de l'étude (Anticipé)

1 septembre 2022

Dates d'inscription aux études

Première soumission

11 juin 2021

Première soumission répondant aux critères de contrôle qualité

20 juin 2021

Première publication (Réel)

22 juin 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 novembre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 octobre 2021

Dernière vérification

1 octobre 2021

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur mini_FC

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