for the Atlanrea Study Group and the Société Française d'Anesthésie Réanimation (SFAR) Research Network IMPORTANCE Fluid therapy is an important component of care for patients with traumatic brain injury, but whether it modulates clinical outcomes remains unclear.OBJECTIVE To 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.INTERVENTIONS Adult 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. RESULTS Among 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 RELEVANCE Among 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.

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Background Fluid infusion represents one of the cornerstones of resuscitation therapies in order to increase oxygen delivery during septic shock. Fluid overload as a consequence of excessive fluid administration seems to be linked to worse long-term outcome. However, its immediate effect on patient’s clinical state is poorly described. The goal of this study was to assess the impact of FO on SOFA score kinetics as a surrogate marker of organ dysfunction from day 0 to day 5. Material and methods Retrospective, multicenter, investigator-initiated study. All adult patients (> 18 years old) admitted from January 2012 to April 2017 in one of the three ICUs for septic shock, secondary to peritonitis or pulmonary infection and mechanically ventilated, were included. Univariate analysis was performed with Student’s t and chi-square test, for continuous and categorical variables, respectively. A multivariate linear regression model evaluated the impact of FO on delta SOFA score from day 0 to day 5. Secondly, a multivariate mixed-model accounting for repeated measures analyzed the impact of FO on SOFA score kinetics. Results One hundred twenty-nine patients met the inclusion criteria and were assigned into FO and no FO groups. FO occurred in 39% of the patients. The difference between SOFA score at day 0 and day 5 was more than twofold higher in the no FO group than in the FO group with a difference of 2.37 between the two groups (4.52 vs. 2.15; p = 0.001). Cumulative fluid intake at day 5 was higher in the FO group (2738 vs. 8715 ml, p < 0.001). In multivariate analysis, FO was associated with delta SOFA score: aRR = 0.15 (95% CI 0.03–0.63; p = 0.009). In mixed model, the regression coefficient for fluid overload status ( r 2 = 1.16; p = 0.014) indicated that the slope for SOFA score kinetic was less pronounced for patients with FO than for patients without FO. Conclusions FO patients had a more prolonged multi-organ failure according to SOFA score kinetics during septic shock from resuscitation phase to day 5. Electronic supplementary material The online version of this article (10.1186/s40560-019-0394-0) contains supplementary material, which is available to authorized users.