Effect of Continuous Infusion of Hypertonic Saline vs Standard Care on 6-Month Neurological Outcomes in Patients With Traumatic Brain Injury
| Autor: | Benjamin Cohen, Kevin Chalard, Olivier Huet, Thomas Gaillard, Véronique Vermeersch, Sigismond Lasocki, Jean Denis Moyer, Pierre Joachim Mahe, Dominique Demeure Dit Latte, Mickael Vourc'h, Karim Asehnoune, Celine Lerebourg, Antoine Roquilly, Caroline Jeantrelle, Fanny Feuillet, Florian Pierre Martin, Claire Dahyot-Fizelier, Philippe Seguin, Raphaël Cinotti, Alice Chopin, Laurent Flet, Anne Chiffoleau |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Traumatic brain injury business.industry Glasgow Outcome Scale 010102 general mathematics Hazard ratio General Medicine Odds ratio medicine.disease 01 natural sciences law.invention Hypertonic saline 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Interquartile range Intensive care Internal medicine medicine 030212 general & internal medicine 0101 mathematics business |
| Zdroj: | JAMA. 325:2056 |
| ISSN: | 0098-7484 |
| DOI: | 10.1001/jama.2021.5561 |
| Popis: | 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 Participants 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. 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 Measures 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. 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. Trial Registration ClinicalTrials.gov Identifier:NCT03143751 |
| Databáze: | OpenAIRE |
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