Antoine\u00a0Roquilly,\u00a0Jean Denis\u00a0Moyer,\u00a0Olivier\u00a0Huet,\u00a0et al<\/h3>\n\n\n\nJAMA.\u00a0<\/em>2021;325(20):2056-2066. doi:10.1001\/jama.2021.5561<\/h3>\n\n\n\nAbstract<\/h2>\n\n\n\nImportance<\/strong><\/h3>\n\n\n\nFluid therapy is an important component of care for patients with traumatic brain injury, but whether it modulates clinical outcomes remains unclear.<\/p>\n\n\n\n
Objective<\/strong><\/h3>\n\n\n\nTo determine whether continuous infusion of hypertonic saline solution improves neurological outcome at 6 months in patients with traumatic brain injury.<\/p>\n\n\n\n
Design, Setting, and Participants<\/strong><\/h3>\n\n\n\nMulticenter 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.<\/p>\n\n\n\n
Interventions<\/strong><\/h3>\n\n\n\nAdult patients with moderate to severe traumatic brain injury were randomly assigned to receive continuous infusion of 20% hypertonic saline solution plus standard care (n\u2009=\u2009185) or standard care alone (controls; n\u2009=\u2009185). The 20% hypertonic saline solution was administered for 48 hours or longer if patients remained at risk of intracranial hypertension.<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong><\/h3>\n\n\n\nThe 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.<\/p>\n\n\n\n
Results<\/strong><\/h3>\n\n\n\nAmong 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;\u00a0P<\/em>\u2009=\u2009.92). 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, \u22122.6% [95% CI, \u221212.3% 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, \u22124.9% [95% CI, \u221212.8% to 3.1%]; hazard ratio, 0.79 [95% CI, 0.48-1.28]).<\/p>\n\n\n\n![\"\"\/](\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938704\/joi210038va_1621617363.87722.png?Expires=1624982429&Signature=rw7T1ohp3eOPrDFdeIZ3pdw-JP~YxEta1PkPPrcqY1N-Mmn0cIHaig6vHqln-sw26faEXPbCPUf64DoVPq8V3cq62VqE8aTkrHxHjPYZRPt3rljGh~MbYwvtlTzPqk~GN16B4sxxkvW9ucbkiu8TB2qhzi2Vtv72YfxjW5x-EXwfE0nbbo44sHmH2ljMdagQrfpMKGYNBZUKoZ705QOMaWLrnVmIezUM7tNYrhrEhF0NPZECfAbAORbjz2yz1AfmipWssDuC-jMHPVcN5Rp6pP3JuyhHPNcaLQsV5iq1bwCH-lbOdJb6tpt9nR4Uji1dAt3NOgLk6b7t3PWcgE2YaA__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\")
<\/figure>\n\n\n\nConclusions and Relevance<\/strong><\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
Trial Registration<\/strong><\/h3>\n\n\n\n
Abstract<\/h2>\n\n\n\nImportance<\/strong><\/h3>\n\n\n\nFluid therapy is an important component of care for patients with traumatic brain injury, but whether it modulates clinical outcomes remains unclear.<\/p>\n\n\n\n
Objective<\/strong><\/h3>\n\n\n\nTo determine whether continuous infusion of hypertonic saline solution improves neurological outcome at 6 months in patients with traumatic brain injury.<\/p>\n\n\n\n
Design, Setting, and Participants<\/strong><\/h3>\n\n\n\nMulticenter 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.<\/p>\n\n\n\n
Interventions<\/strong><\/h3>\n\n\n\nAdult patients with moderate to severe traumatic brain injury were randomly assigned to receive continuous infusion of 20% hypertonic saline solution plus standard care (n\u2009=\u2009185) or standard care alone (controls; n\u2009=\u2009185). The 20% hypertonic saline solution was administered for 48 hours or longer if patients remained at risk of intracranial hypertension.<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong><\/h3>\n\n\n\nThe 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.<\/p>\n\n\n\n
Results<\/strong><\/h3>\n\n\n\nAmong 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;\u00a0P<\/em>\u2009=\u2009.92). 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, \u22122.6% [95% CI, \u221212.3% 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, \u22124.9% [95% CI, \u221212.8% to 3.1%]; hazard ratio, 0.79 [95% CI, 0.48-1.28]).<\/p>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong><\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
Trial Registration<\/strong><\/h3>\n\n\n\n
Fluid therapy is an important component of care for patients with traumatic brain injury, but whether it modulates clinical outcomes remains unclear.<\/p>\n\n\n\n
Objective<\/strong><\/h3>\n\n\n\nTo determine whether continuous infusion of hypertonic saline solution improves neurological outcome at 6 months in patients with traumatic brain injury.<\/p>\n\n\n\n
Design, Setting, and Participants<\/strong><\/h3>\n\n\n\nMulticenter 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.<\/p>\n\n\n\n
Interventions<\/strong><\/h3>\n\n\n\nAdult patients with moderate to severe traumatic brain injury were randomly assigned to receive continuous infusion of 20% hypertonic saline solution plus standard care (n\u2009=\u2009185) or standard care alone (controls; n\u2009=\u2009185). The 20% hypertonic saline solution was administered for 48 hours or longer if patients remained at risk of intracranial hypertension.<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong><\/h3>\n\n\n\nThe 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.<\/p>\n\n\n\n
Results<\/strong><\/h3>\n\n\n\nAmong 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;\u00a0P<\/em>\u2009=\u2009.92). 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, \u22122.6% [95% CI, \u221212.3% 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, \u22124.9% [95% CI, \u221212.8% to 3.1%]; hazard ratio, 0.79 [95% CI, 0.48-1.28]).<\/p>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong><\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
Trial Registration<\/strong><\/h3>\n\n\n\n
Multicenter 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.<\/p>\n\n\n\n
Interventions<\/strong><\/h3>\n\n\n\nAdult patients with moderate to severe traumatic brain injury were randomly assigned to receive continuous infusion of 20% hypertonic saline solution plus standard care (n\u2009=\u2009185) or standard care alone (controls; n\u2009=\u2009185). The 20% hypertonic saline solution was administered for 48 hours or longer if patients remained at risk of intracranial hypertension.<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong><\/h3>\n\n\n\nThe 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.<\/p>\n\n\n\n
Results<\/strong><\/h3>\n\n\n\nAmong 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;\u00a0P<\/em>\u2009=\u2009.92). 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, \u22122.6% [95% CI, \u221212.3% 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, \u22124.9% [95% CI, \u221212.8% to 3.1%]; hazard ratio, 0.79 [95% CI, 0.48-1.28]).<\/p>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong><\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
Trial Registration<\/strong><\/h3>\n\n\n\n
The 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.<\/p>\n\n\n\n
Results<\/strong><\/h3>\n\n\n\nAmong 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;\u00a0P<\/em>\u2009=\u2009.92). 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, \u22122.6% [95% CI, \u221212.3% 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, \u22124.9% [95% CI, \u221212.8% to 3.1%]; hazard ratio, 0.79 [95% CI, 0.48-1.28]).<\/p>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong><\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
Trial Registration<\/strong><\/h3>\n\n\n\n
<\/figure>\n\n\n\n