• Antoine Roquilly, Jean Denis Moyer, Olivier Huet, Sigismond Lasocki, Benjamin Cohen, Claire Dahyot-Fizelier, Kevin Chalard, Philippe Seguin, Caroline Jeantrelle, Véronique Vermeersch, Thomas Gaillard, Raphael Cinotti, Dominique Demeure Dit Latte, Pierre Joachim Mahe, Mickael Vourc'h, Florian Pierre Martin, Alice Chopin, Celine Lerebourg, Laurent Flet, Anne Chiffoleau, Fanny Feuillet, Karim Asehnoune, and Atlanrea Study Group and the Société Française d’Anesthésie Réanimation (SFAR) Research Network.
• Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France.
• JAMA. 2021 May 25; 325 (20): 2056-2066.

ImportanceFluid therapy is an important component of care for patients with traumatic brain injury, but whether it modulates clinical outcomes remains unclear.ObjectiveTo determine whether continuous infusion of hypertonic saline solution improves neurological outcome at 6 months in patients with traumatic brain injury.Design, Setting, And ParticipantsMulticenter randomized clinical trial conducted in 9 intensive care units in France, including 370 patients with moderate to severe traumatic brain injury who were recruited from October 2017 to August 2019. Follow-up was completed in February 2020.InterventionsAdult patients with moderate to severe traumatic brain injury were randomly assigned to receive continuous infusion of 20% hypertonic saline solution plus standard care (n = 185) or standard care alone (controls; n = 185). The 20% hypertonic saline solution was administered for 48 hours or longer if patients remained at risk of intracranial hypertension.Main Outcomes And MeasuresThe primary outcome was Extended Glasgow Outcome Scale (GOS-E) score (range, 1-8, with lower scores indicating worse functional outcome) at 6 months, obtained centrally by blinded assessors and analyzed with ordinal logistic regression adjusted for prespecified prognostic factors (with a common odds ratio [OR] >1.0 favoring intervention). There were 12 secondary outcomes measured at multiple time points, including development of intracranial hypertension and 6-month mortality.ResultsAmong 370 patients who were randomized (median age, 44 [interquartile range, 27-59] years; 77 [20.2%] women), 359 (97%) completed the trial. The adjusted common OR for the GOS-E score at 6 months was 1.02 (95% CI, 0.71-1.47; P = .92). Of the 12 secondary outcomes, 10 were not significantly different. Intracranial hypertension developed in 62 (33.7%) patients in the intervention group and 66 (36.3%) patients in the control group (absolute difference, -2.6% [95% CI, -12.3% to 7.2%]; OR, 0.80 [95% CI, 0.51-1.26]). There was no significant difference in 6-month mortality (29 [15.9%] in the intervention group vs 37 [20.8%] in the control group; absolute difference, -4.9% [95% CI, -12.8% to 3.1%]; hazard ratio, 0.79 [95% CI, 0.48-1.28]).Conclusions And RelevanceAmong patients with moderate to severe traumatic brain injury, treatment with continuous infusion of 20% hypertonic saline compared with standard care did not result in a significantly better neurological status at 6 months. However, confidence intervals for the findings were wide, and the study may have had limited power to detect a clinically important difference.Trial RegistrationClinicalTrials.gov Identifier: NCT03143751.

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