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

Martin Dres, Candice Estellat, Jean-Luc Baudel, François Beloncle, Julien Cousty, Arnaud Galbois, Laurent Guérin, Vincent Labbe, Guylaine Labro, Jordane Lebut, Jean-Paul Mira, Gwenael Prat, Jean-Pierre Quenot, Armand Dessap, Reseau Européen de Recherche en Ventilation Artificielle (REVA) research network, Martin Dres, Candice Estellat, Jean-Luc Baudel, François Beloncle, Julien Cousty, Arnaud Galbois, Laurent Guérin, Vincent Labbe, Guylaine Labro, Jordane Lebut, Jean-Paul Mira, Gwenael Prat, Jean-Pierre Quenot, Armand Dessap, Reseau Européen de Recherche en Ventilation Artificielle (REVA) research network

Abstract

Introduction: Fluid 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 analysis: This 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 dissemination: The 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 number: NCT04050007.

Protocol version: V.1; 12 March 2019.

Keywords: adult cardiology; adult intensive & critical care; respiratory medicine (see thoracic medicine).

Conflict of interest statement

Competing interests: MD reports financial support (expertise fees and travel expenses coverage to attend scientific meetings) by Lungpacer Med. Inc.

© 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.

Figures

Figure 1
Figure 1
Flowchart of the patient and study design.
Figure 2
Figure 2
Criteria suggesting weaning failure from cardiac origin. BNP, brain natriuretic peptide; E/A, early (E) over late (A) diastolic wave velocities at the mitral valve; E/e’, E wave over tissue doppler early (e’) wave velocity at the lateral mitral valve annulus.

References

    1. Thille AW, Richard J-CM, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med 2013;187:1294–302. 10.1164/rccm.201208-1523CI
    1. Liu J, Shen F, Teboul J-L, et al. . Cardiac dysfunction induced by weaning from mechanical ventilation: incidence, risk factors, and effects of fluid removal. Crit Care 2016;20:369. 10.1186/s13054-016-1533-9
    1. Bedet A, Tomberli F, Prat G, et al. . Myocardial ischemia during ventilator weaning: a prospective multicenter cohort study. Critical Care 2019;23:321. 10.1186/s13054-019-2601-8
    1. Frutos-Vivar F, Ferguson ND, Esteban A, et al. . Risk factors for extubation failure in patients following a successful spontaneous breathing trial. Chest 2006;130:1664–71. 10.1378/chest.130.6.1664
    1. Upadya A, Tilluckdharry L, Muralidharan V, et al. . Fluid balance and weaning outcomes. Intensive Care Med 2005;31:1643–7. 10.1007/s00134-005-2801-3
    1. Silversides JA, Fitzgerald E, Manickavasagam US, et al. . Deresuscitation of patients with iatrogenic fluid overload is associated with reduced mortality in critical Illness*. Crit Care Med 2018;46:1600–7. 10.1097/CCM.0000000000003276
    1. National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network, Wiedemann HP, Wheeler AP, et al. . Comparison of two fluid-management strategies in acute lung injury. N Engl J Med 2006;354:909–75. 10.1056/NEJMoa062200
    1. Grams ME, Estrella MM, Coresh J, et al. . Fluid balance, diuretic use, and mortality in acute kidney injury. CJASN 2011;6:966–73. 10.2215/CJN.08781010
    1. Marik PE, Linde-Zwirble WT, Bittner EA, et al. . Fluid administration in severe sepsis and septic shock, patterns and outcomes: an analysis of a large national database. Intensive Care Med 2017;43:625–32. 10.1007/s00134-016-4675-y
    1. Hjortrup PB, Haase N, Bundgaard H, et al. . Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the classic randomised, parallel-group, multicentre feasibility trial. Intensive Care Med 2016;42:1695–705. 10.1007/s00134-016-4500-7
    1. Mekontso Dessap A, Roche-Campo F, Kouatchet A, et al. . Natriuretic peptide-driven fluid management during ventilator weaning: a randomized controlled trial. Am J Respir Crit Care Med 2012;186:1256–63. 10.1164/rccm.201205-0939OC
    1. Dres M, Teboul J-L, Monnet X. Weaning the cardiac patient from mechanical ventilation. Curr Opin Crit Care 2014;20:493–8. 10.1097/MCC.0000000000000131
    1. Thille AW, Muller G, Gacouin A, et al. . Effect of Postextubation high-flow nasal oxygen with noninvasive ventilation vs high-flow nasal oxygen alone on reintubation among patients at high risk of extubation failure. JAMA 2019;322:1465. 10.1001/jama.2019.14901
    1. Teboul J-L. Weaning-induced cardiac dysfunction: where are we today? Intensive Care Med 2014;40:1069–79. 10.1007/s00134-014-3334-4
    1. Dres M, Teboul J-L, Anguel N, et al. . Extravascular lung water, B-type natriuretic peptide, and blood volume contraction enable diagnosis of weaning-induced pulmonary edema. Crit Care Med 2014;42:1882–9. 10.1097/CCM.0000000000000295
    1. Mekontso-Dessap A, de Prost N, Girou E, et al. . B-Type natriuretic peptide and weaning from mechanical ventilation. Intensive Care Med 2006;32:1529–36. 10.1007/s00134-006-0339-7
    1. Caille V, Amiel J-B, Charron C, et al. . Echocardiography: a help in the weaning process. Critical Care 2010;14:R120. 10.1186/cc9076
    1. Lamia B, Maizel J, Ochagavia A, et al. . Echocardiographic diagnosis of pulmonary artery occlusion pressure elevation during weaning from mechanical ventilation*. Crit Care Med 2009;37:1696–701. 10.1097/CCM.0b013e31819f13d0
    1. Quintard H, l’Her E, Pottecher J, et al. . Experts’ guidelines of intubation and extubation of the ICU patient of french society of anaesthesia and intensive care medicine (SFAR) and French-speaking intensive care society (SRLF). Ann Intensive Care 2019;9:13. 10.1186/s13613-019-0483-1
    1. Boles J-M, Bion J, Connors A, et al. . Weaning from mechanical ventilation. Eur Respir J 2007;29:1033–56. 10.1183/09031936.00010206
    1. Hernández G, Vaquero C, Colinas L, et al. . Effect of postextubation high-flow nasal cannula vs noninvasive ventilation on reintubation and postextubation respiratory failure in high-risk patients. JAMA 2016;316:1565–74. 10.1001/jama.2016.14194
    1. Leone M, Bouadma L, Bouhemad B, et al. . Hospital-acquired pneumonia in ICU. Anaes Crit Care & Pain Med 2018;37:83–98. 10.1016/j.accpm.2017.11.006
    1. Béduneau G, Pham T, Schortgen F, et al. . Epidemiology of weaning outcome according to a new definition. the wind study. Am J Respir Crit Care Med 2017;195:772–83. 10.1164/rccm.201602-0320OC
    1. Dres M, Teboul J-L, Anguel N, et al. . Passive leg raising performed before a spontaneous breathing trial predicts weaning-induced cardiac dysfunction. Intensive Care Med 2015;41:487–94. 10.1007/s00134-015-3653-0
    1. Shen Y, Zhang W, Shen Y. Early diuretic use and mortality in critically ill patients with vasopressor support: a propensity score-matching analysis. Critical Care 2019;23:9. 10.1186/s13054-019-2309-9
    1. McCoy IE, Montez-Rath ME, Chertow GM, et al. . Estimated effects of early diuretic use in critical illness. Crit Care Explor 2019;1:e0021. 10.1097/CCE.0000000000000021
    1. Martin GS, Mangialardi RJ, Wheeler AP, et al. . Albumin and furosemide therapy in hypoproteinemic patients with acute lung injury*. Crit Care Med 2002;30:2175–82. 10.1097/00003246-200210000-00001
    1. Vincent J-L, Sakr Y, Sprung CL, et al. . Sepsis in European intensive care units: results of the soap study*. Crit Care Med 2006;34:344–53. 10.1097/01.CCM.0000194725.48928.3A
    1. Monnet X, Cipriani F, Camous L, et al. . The passive leg raising test to guide fluid removal in critically ill patients. Ann Intensive Care 2016;6:46. 10.1186/s13613-016-0149-1
    1. Hernández G, Vaquero C, González P, et al. . Effect of postextubation high-flow nasal cannula vs conventional oxygen therapy on reintubation in low-risk patients. JAMA 2016;315:1354–61. 10.1001/jama.2016.2711

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel