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Comparison of a preventive or curative strategy of fluid removal on the weaning of mechanical ventilation: a study protocol for a multicentre randomised open-label parallel-group trial

BMJ open, 2021-08, Vol.11 (8), p.e048286-e048286 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ;2021 Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Distributed under a Creative Commons Attribution 4.0 International License ;Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2021 ;ISSN: 2044-6055 ;EISSN: 2044-6055 ;DOI: 10.1136/bmjopen-2020-048286 ;PMID: 34400454

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  • Title:
    Comparison of a preventive or curative strategy of fluid removal on the weaning of mechanical ventilation: a study protocol for a multicentre randomised open-label parallel-group trial
  • Author: Dres, Martin ; Estellat, Candice ; Baudel, Jean-Luc ; Beloncle, François ; Cousty, Julien ; Galbois, Arnaud ; Guérin, Laurent ; Labbe, Vincent ; Labro, Guylaine ; Lebut, Jordane ; Mira, Jean-Paul ; Prat, Gwenael ; Quenot, Jean-Pierre ; Dessap, Armand Mekontso
  • Subjects: adult cardiology ; adult intensive & critical care ; Alkalosis ; Anesthesia ; Disease prevention ; Diuretics ; Edema ; Extubation ; Guillain-Barre syndrome ; Hemodynamics ; Human health and pathology ; Hypotheses ; Intensive Care ; Intubation ; Kidneys ; Life Sciences ; Metabolism ; Ostomy ; Patients ; Peptides ; Potassium ; respiratory medicine (see thoracic medicine) ; Urine ; Ventilators ; Weaning
  • Is Part Of: BMJ open, 2021-08, Vol.11 (8), p.e048286-e048286
  • Description: IntroductionFluid overload is associated with a poor prognosis in the critically ill patients, especially at the time of weaning from mechanical ventilation as it may promote weaning failure from cardiac origin. Some data suggest that early administration of diuretics would shorten the duration of mechanical ventilation. However, this strategy may expose patients to a higher risk of haemodynamic and metabolic complications. Currently, there is no recommendation for the use of diuretics during weaning and there is an equipoise on the timing of their initiation in this context.Methods and analysisThis study is a multicentre randomised controlled trial comparing two strategies of fluid removal during weaning in 13 French intensive care units (ICU). The preventive strategy is initiated systematically when the fluid balance or weight change is positive and the patients have criteria for clinical stability; the curative strategy is initiated only in case of weaning failure documented as of cardiac origin. Four hundred and ten patients will be randomised with a 1:1 ratio. The primary outcome is the duration of weaning from mechanical ventilation, defined as the number of days between randomisation and successful extubation (alive without reintubation nor tracheostomy within the 7 days after extubation) at day 28. Secondary outcomes include daily and cumulated fluid balance, metabolic and haemodynamic complications, ventilator-associated pneumonia, weaning complications, number of ventilator-free days, total duration of mechanical ventilation, the length of stay in ICU and mortality in ICU, in hospital and, at day 28. A subgroup analysis for the primary outcome is planned in patients with kidney injury (Kidney Disease: Improving Global Outcomes class 2 or more) at the time of randomisation.Ethics and disseminationThe study has been approved by the ethics committee (Comité de Protection des Personnes Paris 1) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04050007.Protocol versionV.1; 12 March 2019.
  • Publisher: London: British Medical Journal Publishing Group
  • Language: English
  • Identifier: ISSN: 2044-6055
    EISSN: 2044-6055
    DOI: 10.1136/bmjopen-2020-048286
    PMID: 34400454
  • Source: ProQuest One Psychology
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