- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT04934943
"Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools" (MINI3)
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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Várható)
Kapcsolatok és helyek
Tanulmányi helyek
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Novara, Olaszország, 28100
- Jelentkezés meghívóval
- Antonio Messina
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Milano
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Rozzano, Milano, Olaszország, 20089
- Toborzás
- Humanitas Research Hospital
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
---|---|
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.
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100 ml of Crystalloids infused over 1 minute - data recording and new baseline - FC 4 ml/kg in 10 minutes - data recording
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Agreement of allocation
Időkeret: immediately after the procedure
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Number of responders and non-responders identified by the MOSTCARE and the Echocardiography with respect to the PICCO system (considered as gold standard)
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immediately after the procedure
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Least significant change of the stroke volume - PICCO
Időkeret: 5 minutes before FC administration
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off-line analysis of the recorded stroke volume change before the test
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5 minutes before FC administration
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Least significant change of the stroke volume - MOSTCARE
Időkeret: 5 minutes before FC administration
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off-line analysis of the recorded stroke volume change before the test
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5 minutes before FC administration
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Least significant change of the stroke volume - Echocardiography
Időkeret: 5 minutes before FC administration
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off-line analysis of the recorded stroke volume change before the test
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5 minutes before FC administration
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ROC curve - PICCO
Időkeret: 1 minute after mini fluid challenge infusion
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ROC curve analysis of stroke volume changes after mini fluid challenge infusion
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1 minute after mini fluid challenge infusion
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ROC curve - MOSTCARE
Időkeret: 1 minute after mini fluid challenge infusion
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ROC curve analysis of stroke volume changes after mini fluid challenge infusion
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1 minute after mini fluid challenge infusion
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ROC curve - Echocardiograhy
Időkeret: 1 minute after mini fluid challenge infusion
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ROC curve analysis of stroke volume changes after mini fluid challenge infusion
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1 minute after mini fluid challenge infusion
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Agreement stroke volume estimation - MOSTCARE versus PICCO
Időkeret: immediately after the procedure
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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.
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immediately after the procedure
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Agreement stroke volume estimation - Echocardiography versus PICCO
Időkeret: immediately after the procedure
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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.
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immediately after the procedure
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Együttműködők és nyomozók
Publikációk és hasznos linkek
Általános kiadványok
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- MINI3
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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