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Randomized Controlled Trial Multicenter Study
Diuretics decrease fluid balance in patients on invasive mechanical ventilation: the randomized-controlled single blind, IRIHS study.
- Raphaël Cinotti, LascarrouJean-BaptisteJBMédecine Intensive et Réanimation, Hôtel Dieu, University Hospital of Nantes, 1 place Alexis Ricordeau, 44093, Nantes, France., Marie-Ange Azais, Gwenhaël Colin, QuenotJean-PierreJPService de Médecine Intensive-Réanimation, CHU Dijon-Bourgogne, Dijon, France.Equipe Lipness, Centre de Recherche INSERM UMR1231 et LabEx LipSTIC, Université de Bourgogne-Franche Comté, Dijon, France.INSERM, CIC 1432, Module Épidémiolog, Pierre-Joachim Mahé, Antoine Roquilly, Aurélie Gaultier, Karim Asehnoune, and Jean Reignier.
- CHU Nantes, Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Guillaume et René Laennec, Université de Nantes, 44800, Saint-Herblain, France.
- Crit Care. 2021 Mar 10; 25 (1): 98.
BackgroundFluid overload has been associated with increased morbidity and mortality in critically ill patients. The goal of this study was to assess the efficacy and safety of a diuretic strategy to overcome positive fluid balance in patients on invasive mechanical ventilation.MethodsDesign: Multicenter, single-blind, randomized-controlled study. Patients were randomized into a diuretic (furosemide) or a control group. Patients were eligible in case of fluid overload defined as in-ICU weight increase ≥ 3%, invasive mechanical ventilation (FiO2 ≤ 60% and PEEP ≤ 10 cm H2O on inclusion) and hemodynamic stabilization. The primary outcome was fluid balance, defined as weight variation from reference weight to successful extubation. The main secondary outcome was the safety of diuretic.Results171 patients were randomized. After 5 exclusions, 166 patients were included in the analysis: 77 in the diuretic and 89 in the control group. Fluid balance was 1.4 [- 2.5 to 4.5] kg in the diuretic and 6.4 [0.5-11.2] kg in the control group (p < 0.001). In the multiple imputation analysis, fluid balance was significantly decreased in the diuretic group (mean difference = - 4.8 95% CI [- 7.3 to - 2.5], p < 0.001). Eleven (14%) patients died in the diuretic group and 16 (18%) patients in the control group (p = 0.5). There was a worsening of Acute Kidney Injury in 67 (75.3%) patients of the control group versus 46 (59.7%) patients in the diuretic group (p = 0.03).ConclusionsIn this multicenter randomized-controlled study, protocolized diuretic therapy reduced fluid accumulation in patients receiving mechanical ventilation and was well tolerated with a favorable safety profile. Trial registration NCT02345681, Registered January 26 2015, Prospectively registered, https://clinicaltrials.gov/ct2/show/NCT02345681?term=02345681&draw=2&rank=1 .
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