Effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients (CONFIDENCE): protocol for a multicentre randomised controlled trial.

Autor: Blok SG; Department of Intensive Care, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands. s.blok@amsterdamumc.nl.; Amsterdam Leiden Intensive care Focused Echography (ALIFE, www.alifeofpocus.com ), Amsterdam, The Netherlands. s.blok@amsterdamumc.nl.; Amsterdam Leiden Intensive care Focused Echography (ALIFE, www.alifeofpocus.com ), Leiden, The Netherlands. s.blok@amsterdamumc.nl., Mousa A; Amsterdam Leiden Intensive care Focused Echography (ALIFE, www.alifeofpocus.com ), Amsterdam, The Netherlands.; Amsterdam Leiden Intensive care Focused Echography (ALIFE, www.alifeofpocus.com ), Leiden, The Netherlands.; Department of Intensive Care, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan, 1117, Amsterdam, Netherlands., Brouwer MG; Department of Intensive Care, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.; Amsterdam Leiden Intensive care Focused Echography (ALIFE, www.alifeofpocus.com ), Amsterdam, The Netherlands.; Amsterdam Leiden Intensive care Focused Echography (ALIFE, www.alifeofpocus.com ), Leiden, The Netherlands., de Grooth HJ; Department of Intensive Care, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan, 1117, Amsterdam, Netherlands., Neto AS; Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.; Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.; Department of Critical Care, Melbourne Medical School, University of Melbourne, Austin Hospital, Melbourne, Australia.; Department of Intensive Care, Austin Hospital, Melbourne, Australia., Blans MJ; Department of Intensive Care, Rijnstate Hospital, Arnhem, Netherlands., den Boer S; Department of Intensive Care, Spaarne Gasthuis, Haarlem, Hoofddorp, Netherlands., Dormans T; Department of Intensive Care, Zuyderland Medical Centre, Heerlen, Netherlands.; Department of Intensive Care, Zuyderland Medical Centre, Sittard-Geleen, Netherlands., Endeman H; Department of Intensive Care, Erasmus MC, Rotterdam, Netherlands., Roeleveld T; Department of Intensive Care, Amstelland Hospital, Amstelveen, Netherlands., Scholten H; Department of Intensive Care, Catharina Hospital, Eindhoven, Netherlands., van Slobbe-Bijlsma ER; Department of Intensive Care, TerGooi MC, Hilversum, Netherlands., Scholten E; Department of Intensive Care, St. Antonius Hospital, Nieuwegein, Utrecht, Netherlands., Touw H; Department of Intensive Care, Radboud University Medical Centre, Nijmegen, Netherlands., van der Ven FSLIM; Department of Intensive Care, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.; Department of Intensive Care, Rode Kruis Hospital, Beverwijk, Netherlands., Wils EJ; Department of Intensive Care, Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands., van Westerloo DJ; Department of Intensive Care, Leiden University Medical Centre, Leiden, Netherlands., Heunks LMA; Department of Intensive Care, Erasmus MC, Rotterdam, Netherlands., Schultz MJ; Department of Intensive Care, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands., Paulus F; Department of Intensive Care, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.; Center of Expertise Urban Vitality, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands., Tuinman PR; Amsterdam Leiden Intensive care Focused Echography (ALIFE, www.alifeofpocus.com ), Amsterdam, The Netherlands.; Amsterdam Leiden Intensive care Focused Echography (ALIFE, www.alifeofpocus.com ), Leiden, The Netherlands.; Department of Intensive Care, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan, 1117, Amsterdam, Netherlands.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Mar 24; Vol. 24 (1), pp. 226. Date of Electronic Publication: 2023 Mar 24.
DOI: 10.1186/s13063-023-07171-w
Abstrakt: Background: Fluid therapy is a common intervention in critically ill patients. It is increasingly recognised that deresuscitation is an essential part of fluid therapy and delayed deresuscitation is associated with longer invasive ventilation and length of intensive care unit (ICU) stay. However, optimal timing and rate of deresuscitation remain unclear. Lung ultrasound (LUS) may be used to identify fluid overload. We hypothesise that daily LUS-guided deresuscitation is superior to deresuscitation without LUS in critically ill patients expected to undergo invasive ventilation for more than 24 h in terms of ventilator free-days and being alive at day 28.
Methods: The "effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients" (CONFIDENCE) is a national, multicentre, open-label, randomised controlled trial (RCT) in adult critically ill patients that are expected to be invasively ventilated for at least 24 h. Patients with conditions that preclude a negative fluid balance or LUS examination are excluded. CONFIDENCE will operate in 10 ICUs in the Netherlands and enrol 1000 patients. After hemodynamic stabilisation, patients assigned to the intervention will receive daily LUS with fluid balance recommendations. Subjects in the control arm are deresuscitated at the physician's discretion without the use of LUS. The primary endpoint is the number of ventilator-free days and being alive at day 28. Secondary endpoints include the duration of invasive ventilation; 28-day mortality; 90-day mortality; ICU, in hospital and total length of stay; cumulative fluid balance on days 1-7 after randomisation and on days 1-7 after start of LUS examination; mean serum lactate on days 1-7; the incidence of reintubations, chest drain placement, atrial fibrillation, kidney injury (KDIGO stadium ≥ 2) and hypernatremia; the use of invasive hemodynamic monitoring, and chest-X-ray; and quality of life at day 28.
Discussion: The CONFIDENCE trial is the first RCT comparing the effect of LUS-guided deresuscitation to routine care in invasively ventilated ICU patients. If proven effective, LUS-guided deresuscitation could improve outcomes in some of the most vulnerable and resource-intensive patients in a manner that is non-invasive, easy to perform, and well-implementable.
Trial Registration: ClinicalTrials.gov NCT05188092. Registered since January 12, 2022.
(© 2023. The Author(s).)
Databáze: MEDLINE
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