Effect of Continuous Infusion of Hypertonic Saline vs Standard Care on 6-Month Neurological Outcomes in Patients With Traumatic Brain Injury: The COBI Randomized Clinical Trial.
Autor: | Roquilly A; Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France., Moyer JD; Department of Anesthesiology and Critical Care, Beaujon Hospital, DMU Parabol, AP-HP Nord, Paris, France., Huet O; CHU de Brest, Anesthesia and Intensive Care Unit, Brest, France., Lasocki S; CHU d'Angers, Anesthesia and Intensive Care Unit, Angers, France., Cohen B; CHU de Tours, Anesthesia and Intensive Care Unit, Tours, France., Dahyot-Fizelier C; CHU de Potiers, Anesthesia and Intensive Care Unit, Poitiers, France., Chalard K; CHU de Montpellier, Anesthesia and Intensive Care Unit, Montpellier, France., Seguin P; CHU de Rennes, Anesthesia and Intensive Care Unit, Rennes, France., Jeantrelle C; Department of Anesthesiology and Critical Care, Beaujon Hospital, DMU Parabol, AP-HP Nord, Paris, France., Vermeersch V; CHU de Brest, Anesthesia and Intensive Care Unit, Brest, France., Gaillard T; CHU d'Angers, Anesthesia and Intensive Care Unit, Angers, France., Cinotti R; Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France., Demeure Dit Latte D; Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France., Mahe PJ; Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France., Vourc'h M; Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France., Martin FP; Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France., Chopin A; Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France., Lerebourg C; Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France., Flet L; CHU de Nantes, Service de pharmacie, Hôtel Dieu, Nantes, France., Chiffoleau A; DRCI, Departement promotion, cellule vigilances, CHU Nantes, Nantes, France., Feuillet F; DRCI, Plateforme de Méthodologie et de Biostatistique, CHU Nantes, Nantes, France.; Université de Nantes, Université de Tours, INSERM, SPHERE U1246, Nantes, France., Asehnoune K; Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d'Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France. |
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Jazyk: | angličtina |
Zdroj: | JAMA [JAMA] 2021 May 25; Vol. 325 (20), pp. 2056-2066. |
DOI: | 10.1001/jama.2021.5561 |
Abstrakt: | 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: | MEDLINE |
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